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Feldstain, A., Lebel, S., & Chasen, M.R. (2016). An interdisciplinary palliative rehabilitation intervention bolstering general self-efficacy to attenuate symptoms of depression in patients living with advanced cancer. Supportive Care in Cancer, 24, 109–117.

Study Purpose

To examine the effects of a palliative rehabilitation program on depression, and explore the impacts and interactions between depression, inflammation, exercise, and self-efficacy.

Intervention Characteristics/Basic Study Process

All patients received group physiotherapy twice a week; all patients also received as treatment plan based on assessment of individual functioning and goals that was implemented during the course of the study, including support, encouragement, feedback, and guidance to motivate patients and encourage positive change. The program was provided during an eight-week period. Study measures were obtained at baseline and at the completion of the program.

Sample Characteristics

  • N = 80
  • AGE = Not provided
  • MALES: 47.5%, FEMALES: 52.5%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types existed. Patients were in stage III or IV. Breast and hematological cancers were most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: ECOG status of 2 or better. 21.3% were taking antidepressants.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Ottawa, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care

Study Design

  • Quasi-experimental

Measurement Instruments/Methods

  • C-reactive protein (CRP) as a marker of inflammation
  • Six-minute walk test (6MWT)
  • General Self-Efficacy Scale
  • Hospital Anxiety and Depression Scale (HADS)

Results

Completion rate for sessions was 69%. There was no change in CRP. Performance on the 6MWT increased (p < 0.001). Self-efficacy scores increased from a mean of 27.86 to 31.23 (p <  0.01). Depression scores decreased on average from 7.14 to 5.95 (p = 0.002).  Analysis showed that exercise results and self-efficacy were significant predictors of change in depression scores. Changes in the 6MWT explained 3% of the change in depression and self-efficacy explained 11%.

Conclusions

The multicomponent rehabilitative intervention tested here was associated with reduced depression scores. Exercise and self-efficacy were shown to be significant predictors of depression scores.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals of 10% or greater 
  • Almost 50% who entered the study did not complete it; about half of these were due to disease progression.
  • Authors state that use of antidepressants was not correlated with change in depression scores; however, it would not necessarily be expected that scores would decline further, and there was no subgroup analysis based on use of antidepressants.
  • The measure used for exercise was a measure of stamina, not exercise intensity or regularity, so their conclusions that exercise may not be as effective for depression is not necessarily accurate.
  • Mean depression score changes were not at a level that was clinically significant, and floor effects of the measure at baseline are possible.
  • It is not known if participants were doing any other interventions for support.

Nursing Implications

Participation in exercise has been associated with improvement in depressive symptoms, and exercising in a group setting may enhance support and its effects on self-efficacy and mood. Findings of this study, however, showed statistically significant changes in depression, but the size of these changes on the measures used was not clinically significant. Research in this area should be aimed at individuals who have clinically relevant depressive symptoms.

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Fekrazad, R., & Chiniforush, N. (2014). Oral mucositis prevention and management by therapeutic laser in head and neck cancers. Journal of Lasers in Medical Sciences, 5, 1–7.

Purpose

STUDY PURPOSE: To assess the effect of low level laser therapy (LLLT) for oral mucositis

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, ISI Web of Knowledge, Google Scholar
 
INCLUSION CRITERIA: Not specified
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 74
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The evaluation method was not described. The study designs varied and were not all described. One case report was also included.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 24
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,383
  • SAMPLE RANGE ACROSS STUDIES: 1–221 patients
  • KEY SAMPLE CHARACTERISTICS: Patients who have had hematopoietic cell transplantation (HCT), patients with head and neck cancer receiving chemotherapy and radiation therapy, patients with other tumor types receiving chemotherapy, and two studies including pediatric cases

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics

Results

Most evidence showed a positive effect of LLLT on oral mucositis in delayed time of onset, lower peak severity, and shortened duration. One study in children showed no benefit of LLLT when optimal dental and oral care were provided.

Conclusions

LLLT is beneficial for the management of oral mucositis; however, ideal wavelengths, timing, and frequency of treatment are unclear.

Limitations

  • Limited search
  • No study quality evaluation

Nursing Implications

LLLT has been shown to be effective in reducing the symptoms of oral mucositis in patients undergoing transplantation and those receiving treatment for head and neck cancer. The specifics for optimal LLLT timing, duration, and so forth have not been determined. Further research on these aspects is needed.

Print

Feinberg, B., Gilmore, J., Haislip, S., Jackson, J., Jain, G., Balu, S., & Buchner, D. (2012). Impact of initiating antiemetic prophylaxis with palonosetron versus ondansetron on risk of uncontrolled chemotherapy-induced nausea and vomiting in patients with lung cancer receiving multi-day chemotherapy. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 20(3), 615–623.

Study Purpose

To examine the risk of uncontrolled chemotherapy-induced nausea and vomiting (CINV) among patients with lung cancer receiving multiday chemotherapy and ondansetron- or palonosetron-initiated prophylactic antiemetic regimens in a community oncology setting

Intervention Characteristics/Basic Study Process

The Georgia Cancer Specialists electronic medical records database was used to identify patients with lung cancer who received multiday cisplatin or carboplatin regimens with ondansetron or palonosetron on day 1 between April 1, 2006, and July 31, 2009. Uncontrolled CINV was identified. Risk for uncontrolled CINV, up to 7 days after last chemotherapy administration, was analyzed at cycle level using logistic regression.

Sample Characteristics

  • The study reported on 362 patients; 209 of these patients received a total of 702 cycles of palonosetron, and 153 patients received 515 cycles of ondansetron.
  • The palonosetron group was significantly older than the ondansetron group (66.8 years old versus 63.9 years old [p < 0.01]).
  • The palonosetron group was 54% female, and the ondansetron group was 53% female.    
  • Patients were diagnosed with lung cancer, received multiday cisplatin or carboplatin regimens, and used palonosetron or ondansetron on day 1 (and did not receive aprepitant on day 1). The palonosetron group received antiemetics every other day, whereas patients in the ondansetron group received ondansetron every day except for the last day, in which they received palonosetron.
  • The palonosetron group had a Charlson comorbidity index of 3.6 and the ondansetron group had a Charlson comorbidity index of 3.5.
  • The palonosetron group included 25 patients with multicancer diagnoses and the ondansetron group included 27 patients with multicancer diagnoses.

Setting

This was a multi-site study based on electronic medical records data from Georgia Cancer Specialist, a community-based practice that included 30 offices and 46 medical oncologists throughout Georgia.

Phase of Care and Clinical Applications

  • Patients were in active treatment.
  • This study has application to late effects and survivorship.

Study Design

This was a retrospective descriptive study using data from an electronic medical records review.

Measurement Instruments/Methods

The rate of uncontrolled CINV events measured from first chemotherapy agent administration of the cycle (start date) through 7 days after the last chemotherapy agent administration (end date) for

  • Assessment of a CINV event using
    • ICD-9-CM codes 787, 787.01, 782.02, 787.03 (nausea/vomiting), and 265.51(dehydration).
    • CPT codes 09760, 90761, 96360, and 96361 (hydration).
  • Rescue medications (NDC code for dexamethasone/Decadron, diphenhydramine/Benadryl, olanzapine/Zyprexa, promethazone/Phenergan, haloperidol/Haldol, prochlorperazine/Compazine, lorazepam/Ativan, or metoclopramide/Reglan).
  • Nausea/vomiting hospitalizations.
  • Oral antiemetic medications and administration of fosaprepitant and aprepitant.
  • IV antiemetic therapy after last chemotherapy administration of the cycle.

Rescue antiemetic after the first day chemotherapy or IV antiemetic after the last chemotherapy administration date were considered as nonprophylactic use.

Results

  • Overall, 273 uncontrolled CINV events were found during 702 platinum cycles in the palonosetron cohort (38.9%) and 455 events were found during 515 cycles (88.4%) in the ondansetron cohort (p < 0.01).
  • Palonosetron cycles had 63% lower risk for uncontrolled CINV events versus ondansetron cycles (OR = 0.37, p < 0.01).
  • Subanalysis by chemotherapy agents supported overall analysis (cisplatin OR = 0.09, p < 0.01, carboplatin OR = 0.46, p < 0.01).

Conclusions

Among patients with lung cancer receiving multiday chemotherapy cycles, administration of palonosetron on day 1 was associated with a significantly lower risk for uncontrolled CINV events versus ondansetron-initiated chemotherapy cycles.

Limitations

  • No appropriate control group was included.
  • Retrospective EMR reviews introduce some limitations. For example, CINV events or hospitalization may have been underestimated, and at-home antiemetic use is not detectable.
  • The palonosetron group was significantly older, which may have lowered CINV risk. Significantly more patients in the palonosetron group received moderately emetogenic chemotherapy than in the ondonsetron group, which may have influenced the comparison between the two.
  • Race, smoking status, and alcohol use were not assessed.

Nursing Implications

For the patients receiving multiple day, platinum based chemotherapy for the treatment of lung cancer, every-other-day palonosetron would be an option to lower the risk of the incidence of uncontrolled CINV.

Print

Fegg, M.J., Brandstatter, M., Kogler, M., Hauke, G., Rechenberg-Winter, P., Fensterer, V., . . . Borasio, G.D. (2013). Existential behavioural therapy for informal caregivers of palliative patients: A randomised controlled trial. Psycho-Oncology, 22, 2079–2086.

Study Purpose

To evaluate the applicability and effectiveness of existential behavioral therapy (EBT)  to informal caregivers of palliative care patients with regards to psychological distress and quality of life when compared with treatment as usual

Intervention Characteristics/Basic Study Process

The intervention was six group sessions totaling 22 hours. The sessions focused on introductions and mindfulness, death, bereavement and mindfulness, activating resources, finding meaning, self-care and stress management, personal values for (re-)orientation, and moving forward. Sessions were administered in small (10 participants or fewer), closed groups by a trained behavioral therapist following a study manual. Evaluations occurred at baseline, pre- and post-intervention, and at 3- and 12-month follow-up (five time points).

Sample Characteristics

  • N = 133  
  • MEAN AGE = 54.5 years (13.2 years)
  • MALES: 30.1%, FEMALES: 69.9%
  • KEY DISEASE CHARACTERISTICS: Primarily (92.7%) various cancer diagnoses and neurological diseases; six months or less to live; currently in an inpatient palliative care unit
  • OTHER KEY SAMPLE CHARACTERISTICS: German speaking; 61.7% identified as partners, 26.3% as parents, 4% as children, and 12% as other

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Inpatient  
  • LOCATION: Munich, Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

  • RCT

Measurement Instruments/Methods

  • Brief Symptom Inventory (BSI) subscales—somatization, anxiety, and depression
  • Quality of life
    • Satisfaction With Life Scale (SWLS)—cognitive aspects
    • World Health Organization Quality of Life (WHOQOL)-BREF
    • Numeric rating scale for quality of life—QOL-NRS (single-item, scale of 1–10)
  • Positive and Negative Affect Scale (PANAS)

Results

EBT showed medium effects at the pre-/immediate post-test evaluation with improvement in anxiety (p 0.006) and on all measures of quality of life (p 0.009, 0.007, < 0.001). At the three-month evaluation, EBT showed no significant effects, with only small effect sizes on one-third of the quality-of-life measure SWLS (p 0.04). However, at the 12-month evaluation, EBT demonstrated medium effects on depression (p 0.04) and QOL-NRS (p 0.002). Interestingly, similar patterns resulted when examining secondary outcomes of affect, with significantly less negative affect demonstrated at post-test (p 0.003), which then was not noted at the three-month evaluation, and at 12 months, significantly less negative affect was measured again (p 0.003). Positive affect, although never significant, always was trending more positive than when compared with controls. High level of satisfaction existed with the group, the therapist, information, mindfulness, and values.

Conclusions

EBT shows promise as an intervention to improve psychological distress and quality of life for carers of patients with cancer at end of life. The effect is greatest immediately following the intervention. Additional work is required with attentional control groups and outpatient patient populations to further support the benefits of this intervention.

Limitations

  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: Heterogeneous sample—variety of care types, partners versus relatives and carers of living and dead patients were included in the same groups, meaning that for some, they already were in the grieving process at the start of the intervention. When compared to treatment as usual, which is no intervention, whether EBT or just being part of a group, or having attention of the therapist accounted for the improved outcomes is unclear. Intervention included specially trained behavioral therapist, not nurses.

Nursing Implications

Interventions such as EBT that target informal carers of patients with cancer have the potential to relieve distress and improve quality of life for the carer and the patient.

Print

Fay, A.P., Moreira, R.B., Nunes Filho, P.R., Albuquerque, C., & Barrios, C.H. (2016). The management of immune-related adverse events associated with immune checkpoint blockade. Expert Review of Quality of Life in Cancer Care, 1, 89–97. 

Purpose & Patient Population

PURPOSE: To review article
 
TYPES OF PATIENTS ADDRESSED: Immune checkpoint blockade therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion

PROCESS OF DEVELOPMENT: Review article
 
DATABASES USED: None
 
INCLUSION CRITERIA: None
 
EXCLUSION CRITERIA: None

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference

Review article

Guidelines & Recommendations

General guidelines: Grade 2: Treatment break until toxicity is grade 1 or less, prednisone 0.5 mg/kg/day or equivalent start if no improvement in symptoms occur after a few days. Grade 3–4: Prednisone 1–2 mg/kg/day or equivalent; after toxicity is grade 1, taper steroid over a few weeks. Immune therapy may need to be discontinued.
 
Rash: Topical steroids, such as betamethasone 0.1% or clobetasol 0.05%. Grade 2: Topical or oral steroids, such as prednisone, dosed up to 0.5 mg/kg/day or equivalent. Grade 3: IV methylprednisolone 1–2 mg/kg/day or equivalent. When rash improves, switch to oral therapy and taper carefully.
 
Diarrhea: Grade 1–2: Antidiarrheal agents, oral hydration and electrolytes, diet changes, and antimotility agents. Persisting Grade 2 diarrhea: 4–6 stool/day for more than three days; steroid 0.5 mg/kg/day prednisolone or equivalent; with improvement in diarrhea, taper steroids over four weeks. Grade 3–4: Seven stools/day or more; colonoscopy or CT abdomen; stool for leucocytes and culture; IV fluids; and IV steroids, such as methylprednisolone, 125 mg followed by oral steroids prednisone 1–2 mg/kg or equivalent. Infliximab 5 mg/kg every two weeks if colitis does not improve in 2–3 days. Taper steroids over 6–8 weeks after improvement.  
 
Dyspnea—severe toxicity: 1–2 mg/kg IV steroid; if no improvement, infliximab or other immune-suppressant agents may be used.

Limitations

Literature review of common checkpoint inhibitor adverse and serious adverse events. No evidence quality review was provided.

Nursing Implications

Research is needed on the management of checkpoint inhibitor therapy toxicities.

Print

Farquhar, M.C., Prevost, A.T., McCrone, P., Brafman-Price, B., Bentley, A., Higginson, I.J., . . . Booth, S. (2014). Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial. BMC Medicine, 12, 194-014-0194-2. 

Study Purpose

To evaluate the effects of a specialized breathlessness intervention service compared to usual care

Intervention Characteristics/Basic Study Process

The breathlessness intervention service (BIS) was a multidisciplinary complex intervention including nonpharmacologic and pharmacologic interventions to support patients with advanced disease and dyspnea. The BIS used first-stage interventions such as positioning to reduce the work of breathing, education, individualized exercise plans, relaxation techniques, sleep hygiene, cognitive behavioral therapy approaches, and other supports. Second-stage interventions applied concurrently included opioids, antidepressants, anxiolytics, etc. Patients referred to this service were randomly assigned to the intervention or to a wait-list control group. Study measures were obtained at baseline and after the intervention. Interviews were done before randomization, at two weeks, and at five weeks. The interviews were recorded and transcribed verbatim for analysis. A final qualitative analysis was done from 20 intervention transcripts that were purposefully sampled to obtain a diverse group from those who improved and did not improve.

Sample Characteristics

  • N = 54 (47 completed five-week evaluations, 39 respondents)
  • MEAN AGE = 69 years (SD = 11.5 years)
  • MALES: 59%, FEMALES: 41%
  • KEY DISEASE CHARACTERISTICS: Lung cancer was most prevalent

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Distress scores caused by breathlessness
  • Hospital Anxiety and Depression Scale (HADS)
  • Chronic Respiratory Questionnaire (CRQ)
  • Numeric Rating Scale (NRS) for distress
  • EuroQol Five Dimensions Questionnaire (EQ 5-D) for generic health status

Results

Patients in the intervention group had greater reductions in breathlessness (1.68 versus 0.23 points, p = 0.049). There were no other significant differences in outcomes for patients or caregivers between study groups. Interventions identified as helpful were providing and teaching the use of a handheld fan, encouraging exercise, coaching in breathing techniques and positioning, medication changes, and referrals to other services. Total costs were lower for the intervention group, and a cost effectiveness analysis showed a 66.4% likelihood that the intervention would result in lower cost and better outcomes in terms of reduced distress from breathlessness. Scores for mastery of symptom management did not change significantly.

Conclusions

This complex psychoeducational and pharmacologic intervention was associated with reduced distress from breathlessness. No effects on patient or caregiver distress, anxiety, or depression were found.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: With this complex, multicomponent intervention, it was not possible to determine which aspects were most effective in achieving improved outcomes.

Nursing Implications

Individual interventions such as opioid use have been shown to reduce dyspnea, so it was not possible to determine the relative value and utility of the combined interventions examined here. These study findings suggested that multicomponent, complex interventions to improve symptoms of breathlessness can be cost effective and improve outcomes.

Print

Faria, C., Li, X., Nagl, N., & McBride, A. (2014). Outcomes associated with 5-HT3-RA therapy selection in patients with chemotherapy-induced nausea and vomiting: A retrospective claims analysis. American Health and Drug Benefits, 7, 50–58.

Study Purpose

To evaluate the clinical and economic impact of delayed chemotherapy-induced nausea and vomiting (CINV) on patients who received initial and maintenance therapy with the 5-hydroxytryptamine 3 (5HT3) receptor antagonist palonosetron compared to older agents

Intervention Characteristics/Basic Study Process

There was no intervention in this retrospective study; however, the procedure was outlined. Using the OptumInsight® database, researchers evaluated the impact of 5HT3 on chemotherapy-naïve patients. This database provided information on all pharmacy and medical claims for each subject, and records were accessed six months prior to the initial chemotherapy treatment and six months after. Patients were not evaluated if the type of antiemetic changed or if chemotherapy was changed. ICD9 codes and pharmacy charges were monitored for primary or secondary diagnoses of nausea, vomiting, and dehydration. Economic outcomes also were evaluated and calculated.

Sample Characteristics

  • N = 26,974
  • AVERAGE AGE = 55.7 years
  • MALES: 30.9%, FEMALES: 69.1%
  • KEY DISEASE CHARACTERISTICS: Patients who were chemotherapy-naïve; not receiving multiday chemotherapy; 53% breast; 20% lung; remainder split between ovarian, colon, and other cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: 72% of patients had a diagnosis for a single site.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified  
  •  LOCATION: OptumInsight database

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care and palliative care

Study Design

Retrospective database analysis

Measurement Instruments/Methods

No instruments were used, but information extracted from the database included patient and treatment characteristics, nausea, vomiting, Charlson Comorbidity Index scores, antiemetic therapy, and specific 5HT3 use.

Results

Preindex comorbidity scores were lowest in the palonosetron group and highest in the dolasetron group. The overall rate for delayed CINV at cycle 1 was 15.6% for all groups. When compared to palonosetron, patients who received ondansetron (p < 0.002), granisetron (p < 0.001), and dolasetron (p = 0.002) had higher rates of CINV in the second and subsequent cycles of chemotherapy. Dexamethasone was consistently used in the first cycle for all treatment groups. Aprepitant was used most often in the palonosetron group (10.7%) compared to ondansetron (3.6%), granisetron (2.3%), and dolasetron (2.5%).

Conclusions

5HT3 agents were effective in preventing CINV. There were differences in 5HT3 efficacy and cost. Delayed CINV rates increased with subsequent cycles of older 5HT3 agents. Palonosetron showed improvement over time. Similar trends were seen with healthcare resource use.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described 
  • Other limitations/explanation: Comorbidities were lowest in the palonosetron group. The palonosetron group received aprepitant more often than the other groups. This may have influenced the outcome measures. This was a claims analysis, and cases of delayed CINV may not have been captured, especially when patients were given a supply of antiemetics to use at home. This study only included patients who were commercially insured. It did not capture any complementary methods that may have been used (i.e., acupressure, nutraceutical).

Nursing Implications

This study demonstrated cost effectiveness. Medical costs constituted the largest costs. Costs were higher if a patient experienced CINV. Nurses need to use guidelines and risk factors when starting patients on chemotherapy. Using a 5HT3 agent based on the emetogenic potential of chemotherapy is important.

Print

Fares, K.M., Mohamed, S.A., Abd El-Rahman, A.M., Mohamed, A.A., & Amin, A.T. (2015). Efficacy and safety of intraperitoneal dexmedetomidine with bupivacaine in laparoscopic colorectal cancer surgery, a randomized trial. Pain Medicine, 16, 1186–1194. 

Study Purpose

To investigate the safety and efficacy of intraperitoneal bupivacaine and dexmedetomidine in patients undergoing laparascopic colorectal surgery for postoperative pain management

Intervention Characteristics/Basic Study Process

Patients were randomized to one of three groups: (a) control (intraperitoneal injection of saline), (b) bupivacaine only (125 mg, 0.25%) injection, and (c) combined dexmedetomidine and bupivacaine (bupivacaine 0.25% and 1 mcg/kg dexmedetomidine). After hemostasis was achieved in surgery, intraperitoneal instillation of study drugs was sprayed uniformly into the periotoneal cavity guided by camera. Pain was assessed at baseline and at 2, 3, 6, 8, 12, and 24 hours postoperatively. IV tramadol (100 mg) was given when pain was at least 3 or upon patient request.

Sample Characteristics

  • N = 45   
  • MEAN AGE = 50 years 
  • MALES: 53.3%, FEMALES: 45.6%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: All had colorectal cancer and were undergoing laparascopic surgical procedures. Most were undergoing hemicolectomy. Others had anterior resections.
  • OTHER KEY SAMPLE CHARACTERISTICS: No differences existed between groups in duration of surgery.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Egypt

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, placebo-controlled, three-group, randomized trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) for pain severity
  • Observer's Assessment of Alertness/Sedation Scale (OAA/S)

Results

The group that received bupivacaine and dexmedetomidine had significantly lower pain at 2, 4, and 24 hours compared to the other study groups (p < 0.03) and needed rescue analgesic much later (p = 0.0002). No difference in time to analgesia existed between study groups 1 and 2. Average overall postoperative tramadol consumption was lower in the group receiving the combined intraperitoneal analgesia (p = 0.001).

Conclusions

Intraperitoneal administration of bupivacaine and dexmedetomidine improved the effectiveness and duration of postoperative analgesia compared to bupivacaine alone or placebo.

Limitations

  • Small sample (< 100)

 

Nursing Implications

Findings showed that loco-regional analgesic administration after laparoscopic colorectal surgery was effective for postoperative analgesia, and the addition of dexmedetomidine to bupivacaine improved efficacy and duration of analgesic effect.

Print

Fares, K.M., Mohamed, S.A., & Abdel-Ghaffar, H.S. (2014). High dose intrathecal morphine for major abdominal cancer surgery: A prospective double-blind, dose-finding clinical study. Pain Physician, 17, 255–264.

Study Purpose

To investigate the safety and efficacy of three doses of intrathecal morphine in patients receiving major abdominal surgery

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive 0.2 mg, 0.5 mg, or 1 mg of morphine injected into the L3-4 space prior to anesthesia. All patients received the same type of anesthesia and reversal. Vital signs and Visual Analog Scales for pain were assessed at six, 12, 18, 24, 36, 48, and 72 hours postoperatively. At patient request, or for a pain score greater than or equal to 3, rescue analgesia of 100 mg IV tramadol was given.

Sample Characteristics

  • N = 90  
  • MEAN AGE = 50.45 years (range = 35–64 years)
  • MALES: Not provided  
  • FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Patients had surgeries including pelvic excentration, hemicolectomy, sigmoidectomy, cystectomy, and hysterectomy. The majority of procedures were American Society of Anesthesiologists class 2.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Egypt

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Double-blinded, randomized trial

Measurement Instruments/Methods

  • Time till first analgesic request
  • Total analgesic consumption
  • Observers Assessment of Alertness/Sedation (OAA/S)
  • Postoperative adverse effects
  • Visual Analog Scale (VAS)

Results

The mean time in hours till the first analgesic request was longer in those receiving 0.5 mg (22.13, p < 0.001) and 1 mg (30.83 , p < 0.001) of morphine. Mean total tramadol consumption also was lower in these groups (p < 0.001) with the lowest consumption in those receiving 1 mg (p < 0.04). For the first 18 hours postoperatively, those receiving higher doses of intrathecal morphine had lower pain scores (p < 0.02) than those receiving 0.2 mg. At 24 hours and beyond, there were no significant differences in pain scores among groups. More patients in the higher dose groups developed pruritus (p = 0.01). There were no other significant differences in overall adverse effects between groups. One older patient in the 1 mg dose group developed respiratory depression.

Conclusions

Doses of 0.5 mg and 1 mg intrathecal morphine preoperatively resulted in longer postoperative pain control and less analgesic consumption with nonsignificant differences in adverse effects compared to a dose of 0.2 mg.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)

 

Nursing Implications

The provision of high-dose intrathecal morphine preoperatively resulted in improved postoperative pain control among patients receiving major abdominal surgeries for cancer. Higher doses were associated with better pain outcomes for the first 24–48 hours after surgery. The administration of high-dose intrathecal morphine necessitated careful patient selection and strict postoperative monitoring.

Print

Fallon, M.T., Storey, D.J., Krishan, A., Weir, C.J., Mitchell, R., Fleetwood-Walker, S.M., . . . Colvin, L.A. (2015). Cancer treatment-related neuropathic pain: Proof of concept study with menthol—A TRPM8 agonist. Supportive Care in Cancer, 23, 2769–2777. 

Study Purpose

To evaluate whether a topical menthol product has clinical benefit for pain of peripheral neuropathy

Intervention Characteristics/Basic Study Process

Patients were given a 1% menthol in aqueous cream and were instructed how to apply it to the affected area and corresponding dermatome region of the spine twice daily. Patients were followed for four to six weeks.

Sample Characteristics

  • N = 40  
  • MEAN AGE = 61 years
  • AGE RANGE = 20–89 years
  • MALES: 37%, FEMALES: 63%
  • KEY DISEASE CHARACTERISTICS: Patients had chronic neuropathic pain: 80% had chemotherapy-induced peripheral neuropathy diagnosed by a physician, and 20% had scar pain related to treatment for breast cancer. Breast and colon cancers were the most common. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Median of 11 months since chemotherapy treatment

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Open-label

Measurement Instruments/Methods

  • Brief Pain Inventory-Short Form (BPI-SF)
  • Hospital Anxiety and Depression Scale (HADS)
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
  • Walking ability: GAITRite mat to measure velocity and cadence
  • Hand dexterity
  • Quantitative sensory testing (QST)

Results

Eighty-two percent showed an improvement in pain scores (p < 0.001). Significant improvements were observed in some aspects of quantitative sensory testing for mechanical detection threshold, cool stimulus, and warm stimulus. Both walking velocity and cadence improved. No significant changes in hand dexterity or LANSS scores were reported.

Conclusions

The findings suggest that the topical application of menthol can improve symptoms of chronic chemotherapy-induced peripheral neuropathy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Subject withdrawals ≥ 10%

Nursing Implications

This study is limited by its small sample size and study design, but shows promising proof of concept results related to molecular receptors in sensory nerves that appear to respond to topical menthol. Very few interventions have been shown to prevent or effectively treat chemotherapy-induced peripheral neuropathy, so further research on the use of topical menthol is warranted. Further well designed studies are needed.

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