To examine the evidence related to intraspinal analgesia and outline resources required to support patients with cancer-related pain

Databases searched were MEDLINE (1950-2008), EMBASE (1980-2008), CINAHL (1982-2008), and the Cochrane Database. A Google internet search was also performed.

Search keywords were intraspinal, epidural, intrathecal injections, pain, cancer, and study design terms for randomized controlled trials and systematic reviews.

Studies were included in the review if they

• Used a randomized controlled trial (RCT) study design, were systematic reviews of RCTs, or were clinical practice guidelines.
• Involved patients of any age and gender experiencing cancer-related pain.
• Compared intraspinal techniques alone or in combination with different intraspinal techniques or other pain management interventions, compared external versus internal pumps, or evaluated timing of intraspinal techniques.
• Measured pain outcomes with a validated scale.

Studies and reviews were excluded if they

• Used intraspinal techniques for procedure-related pain.
• Were not in the English language.
• Were case reports, letters, comments, or news only.

Three systematic reviews, three consensus conferences, and 12 RCTs met the inclusion criteria for evidence of effectiveness. The Appraisal of Guidelines for Research and Evaluation instrument was used to evaluate guidelines. Indicators to evaluate the quality of the other references were publication status (full versus abstract), statement of statistical power or sample size calculation, intention-to-treat analysis, and statement of sponsorship or funding. The final collection of references were eight practice guidelines (which included four local, internal-use, clinical care algorithms or policy and procedure documents and one practice standard), two systematic reviews, and 12 RCTs. Specific information was provided for two systematic reviews, one consensus statement, and 12 RCTs.

• The studies involved a total of 617 patients with samples ranging from 10–102.
• Ages ranged from 22–82 years.
• Follow-up in RCTs ranged from 18 hours to 169 days.
• Most patients included in RCTs had refractory pain.

• Three studies compared intraspinal pain management to other interventions. Of these, two had small sample sizes and showed no differences. The other study, which involved 202 patients, showed reduced pain on a visual analog scale (p = 0.055) and significant reduction in fatigue and depressed consciousness with intrathecal pain management (p < 0.05). Crossover analysis showed greater clinical success with combined therapy.
• Seven RCTs compared different types of drugs or compared drugs with placebos. Most of these studies had small samples and demonstrated mixed results.
• Two small RCTs compared different intraspinal techniques, including epidural infusion by internal pump, intermittent bolus via porta catheter, and epidural administration of morphine in the thoracic versus cervical regions. No differences in pain outcomes were found. The thoracic route was associated with a greater rate of adverse effects.
• Five documents addressed contraindications for intraspinal analgesia, such as anticoagulation, active systemic or local infection, and neurologic conditions such as unstable central nervous system (CNS) disorders and spinal canal pathology. Unmotivated and noncompliant patients also were identified as contraindicated to this approach.
• Documents addressing care needs discussed equipment types, aftercare, monitoring, hospital discharge, follow-up, interprofessional roles, professional education and competencies, patient and family education, and patient safety. The need to prevent infection and to monitor catheter malposition, vital signs, and complications were emphasized. Recommendations included certification of staff who administer intraspinal analgesia, patient protection from infection, appropriate patient monitoring, and comprehensive discharge planning to support this therapy.
• Indications that were supported across all consensus documents for this therapy were intractable pain that could not be controlled by other methods and side effects from conventional routes that prevented dose escalation.
• The most clinically relevant findings were with the use of nonopioids.

Intraspinal analgesia for cancer pain has been shown to provide adequate pain control and fewer side effects than conventional therapy. Because this is an infrequent intervention, high-quality evidence evaluating effectiveness is limited; however, effectiveness has been demonstrated in carefully selected patient groups with intractable pain. Nonopioid effectiveness suggests that use may be most beneficial in situations of opioid refractory pain.

The intraspinal route should be considered as part of a comprehensive pain management strategy. To ensure patient safety, this approach requires appropriate resources and staff guidance via policy and procedures.

To assess the efficacy of Octenidol^®, Glandomed^®, and chlorhexidine mouthwash in the prevention of mucositis and the reduction of the oropharyngeal flora

An oral rinse of 100 ml with 50 cc of chlorhexidine or Octenidol was applied to buccal, pharyngeal, gingival, and tooth surfaces for 30 seconds four times per day in the strata 1 group. The strata 2 group used a Glandomed solution 100 ml rinse with 500 cc of Glandomed or Octenidol applied to pharyngeal, gingival, and tooth surfaces for 30 seconds four times a day. Oral swab samples were taken and incubated for 36–48 hours.

• N = 93  
• MEAN AGE RANGE = 41.4–65.2 years
• MALES: 70.7% (strata 1); 84% (strata 2), FEMALES: 31% (strata 1); 52.2% (strata 2)
• KEY DISEASE CHARACTERISTICS: Strata 1 included patients who were ventilated for ≥ 24 hours independently of a specific diagnosis. Patients randomized to strata 2 received myeloablative, allogeneic, or autologous hematopoietic stem cell transplantation after receiving high-dose chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were aged 18 years or greater and were admitted inpatients. 

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital Marburg in Germany

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care and palliative care 

Prospective, double-blinded, randomized, controlled study dividing patients into two strata

• The Oral Mucositis Assessment Scale (OMAS) and World Health Organization (WHO) mucositis scoring systems were used to determine levels of mucositis.
• A statistic analysis was performed using the SPSS package.

Both strata showed low OMAS and WHO scores, which did not differ significantly between the groups. Overall oropharyngeal flora was significantly reduced in the Octenidol group compared to the chlorhexidine and Glandomed groups.

All solutions resulted in low grades of mucositis according to the OMAS and WHO scoring systems. Octenidol reduced oropharyngeal flora more than chlorhexidine and Glandomed.

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

In this study, Octenidol proved to be superior to chlorhexidine and Glandomed in reducing oropharyngeal flora. This could potentially reduce the occurrence of hospital-acquired infections and ventilator-associated pneumonia.

To see the preventive effect of a sage tea–thyme–peppermint hydrosol oral rinse used in combination with oral care

This study aimed at discovering the preventive effect of sage tea–thyme–peppermint hydrosol oral rinse four times a day in addition to oral care (saline rinse and teeth brushing) in patients receiving chemotherapy regimens using 5-fluorouracil (5-FU). The study collected data through a patient questionnaire, the World Health Organization (WHO) Oral Toxicity Scale, oral cavity photos, and compliance checklists. The study completed assessments at 5 and 14 days after the completion of chemotherapy.

• N = 60, 30 in control group and 30 in intervention   
• MEAN AGE = intervention group: 52.6 years (SD = 8.2 years), control group: 48.7 years (SD = 10 years)
• MALES: 40%, FEMALES: 60%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Colon cancer (majority), solid tumor 
• OTHER KEY SAMPLE CHARACTERISTICS: Denture use varied in the control and intervention groups.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Ankara, Turkey

PHASE OF CARE: Active antitumor treatment

Patients receiving bolus or infusion of 5-FU chemotherapy were randomly assigned to the intervention or control group.

Measurement tools used included a patient questionnaire, the WHO Oral Toxicity Scale, oral cavity photos, and compliance checklists (self-reported by the patients).

Using kappa analysis, the kappa coefficient on day 5 was 0.98 and on day 14 was 0.85 in the intervention group. Oral mucositis in the invention group occurred in 30% of patients compared to 60% of patients in the intervention group. Grade 1 mucositis was statistically lower in the intervention group (10%) versus the control group (53.3%) on day 5 (p < 0.001). Grade 2 mucositis occurred more in the intervention group (20%) versus the control group (6.7%); on day 5, there was no statistical significance. On day 14, 93% of patients in the intervention group did not have mucositis and 96% in the control group did not have mucositis. No grade 3 or 4 mucositis occurred during this study.

Oral mucositis occurred in only 30% of the intervention group compared to 60% of the control group. The sage tea–thyme–peppermint hydrosol rinses are cost-effective, well tolerated, safe, and noninvasive. This intervention may be effective, but more randomized, controlled clinical trials of different types of treatment, as well as larger sample sizes, are needed.

• Small sample (< 100)
• Risk of bias (no blinding)
• Lack of follow-up
• Some patient-reported data

This intervention is a low-cost, effective, and well tolerated intervention. One downside is that this hydrosol needs refrigerated, and the solution needs to be analyzed in the pharmacy for consistency. Nurses need to educate patients and reinforce the importance of oral hygiene and adherence to the schedule of oral rinsing with this solution four times a day. This intervention may be effective but needs more research and data to show its effectiveness.

To determine the effectiveness of a standardized yoga intervention compared to usual care for improving sleep quality among cancer survivors

Patients were stratified by sex and baseline sleep disturbance and randomized to yoga or usual care groups. Patients in the yoga group participated in a program of gentle Hatha yoga and restorative yoga for four weeks. Sessions were provided in community-based sites (e.g., community centers, yoga studios) in groups of 10–15 patients. Study measures were obtained at baseline and at the end of the four-week sessions.

• N = 221
• MEAN AGE = 54.1 years
• MALES: 4%, FEMALES: 96%
• KEY DISEASE CHARACTERISTICS: 75% had breast cancer; 91% had previous surgery; 71% had chemotherapy; 66% had radiation therapy; 51% were on current hormone therapy; the average time since cancer treatment was 16.3 months.
• OTHER KEY SAMPLE CHARACTERISTICS: 48% were not exercising at baseline; 72% were married or in a long-term relationship; all reported at least a level 3 of sleep disturbance on a 10-point numeric scale.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: United States

• PHASE OF CARE: Transition phase after active treatment

• RCT
  • Single-blind

• Pittsburgh Sleep Quality Index
• Actigraphy

Those assigned to the yoga intervention attended an average of 6.5 of 8 prescribed sessions. Compared to patients in the control group, participants in the yoga program showed greater improvement in global sleep quality (OR 10.79, p = .009), less daytime dysfunction (OR 0.381, p < .001), less sleep medication use (OR 0.561, p = .046), and improvement in subjective sleep quality (OR 0.631, p =.047). Global sleep quality, sleep disturbance, sleep efficiency, and subjective sleep quality also improved in patients in the control group. No significant differences were seen between groups in actigraphy findings.

Participation in group yoga sessions had a positive impact on self-reported sleep quality among cancer survivors.

• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals of 10% or greater
• Other limitations/explanation: At baseline, global sleep quality was higher in the intervention group; however, no analysis was provided of the significant of this difference. Use of other interventions for sleep are not discussed, other than sleep medication use, which is not defined. Sessions were done in groups, so to what extent effects seen were because of the yoga exercises versus the group activity and relationships is unclear. The dropout rate was almost 50% in both study groups.

Findings suggest that participation in group yoga sessions may be effective in improving self-reported sleep quality among cancer survivors. This type of activity may not be acceptable to all patients, given the dropout rates seen in this study. However, for those who are interested in this type of intervention, nurses can let patients know that it can be of benefit.

To examine the efficacy of polarity therapy (PT) for reducing cancer-related fatigue and improving health-related quality of life (HRQOL) in women receiving radiation treatments for breast cancer.

Patients were treated with one of three arms: standard clinical care, standard clinical care plus three modified massages, or standard clinical care plus 3 PT treatments. Patients were asked to lie on their back and stomach, and treatments lasted about 75 minutes. For the PT treatments, the therapist used hand positions to examine energy flow, discover trigger points, and restore homeostatic energy flow. For the modified massage treatments, therapists used a modified Swedish massage applied over the clothing, and areas to be massaged were left to the discretion of the patients. Information was collected through daily diaries and weekly questionnaires completed by the patients. Participants were recruited by a clinical research coordinator with a referral from their treating oncologist.

• Final sample size used for the analysis was 43 female participants.
• Mean age was 52.9 years. 
• All participants were diagnosed with breast cancer (stage 0–IV).
• Thirty-eight of 43 patients were Caucasian.

This was a randomized, controlled trial.

• The Brief Fatigue Inventory (BFI) was used for the primary outcome measure. 
• Daily fatigue diaries were used to assess fatigue at its worst during the day and were completed at bedtime.
• HRQOL was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue.

The baseline BFI showed a significant difference in baseline fatigue scores. The standard care group had a mean of 1.8, the massage mean was 3.0, and the PT mean was 3.7.  BFI scores, fatigue diaries, and HRQOL measures across the three intervention weeks showed no significant differences between the three groups.

This study did not show a significant improvement in fatigue scores between the groups. The interventions were well received by participants, and no adverse effects were reported, suggesting that this intervention could be further studied with a larger sample size.

• The study had a control group that received less attention due to a lack of therapeutic interventions compared to the other two groups, but the massage arm seemed to suggest an effective method to control for attention.
• The study group was comprised of one diagnosis and gender.

To determine the efficacy of palonosetron combined with dexamethasone in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiple-day chemotherapy and the efficacy of a second dose of palonosetron in treating breakthrough emesis

An historic control group was used. Group O received ondansetron (8 mg IV) as a single dose on day one, along with dexamethasone each day of the regimen. Breakthrough emesis was treated with metoclopramide in the control group (but only after 72 hours following the first dose).

• The study consisted of 91 participants, which included 45 historic cases.
• The median age in the study group (P) was 51 years with a range of 15–80. The median age in the control group (O) was 50 years with a range of 20–77.
• The study sample was 37% female and 63% male; the control sample was 40% female and 60% male.
• Diagnoses were non-Hodgkin lymphoma, Hodgkin lymphoma, and acute myeloid leukemia.
• Patients in both the control and study groups received similar chemotherapy regimens with a total of 180 total cycles of chemotherapy administered in the study group and 173 cycles administered in the control group.

This study was conducted at a single inpatient setting in Palermo, Italy.

All patients were in active treatment.

This was a prospective trial with historic control comparison.

The number of vomiting episodes, grade of nausea (grading scale included), and need for rescue therapy were recorded in patient diaries.

• Nausea and vomiting were absent in 80% of patients of the study (P) group and 60% in the control (O) group (p < 0.05).
• In the study (P) group, 67% of patients who experienced CINV were successfully rescued by a second dose of palonosetron, whereas in the ondansetron group, 22% were successfully rescued after treatment with metoclopramide (p = 0.04).

Palonosetron was effective for prophylaxis of CINV and for treatment of breakthrough emesis in the setting of multiple-day chemotherapy.

• No concurrent control or random patient assignment was used.
• Use of retrospective comparison to ondansetron is based on the premise that repeat dosing of ondansetron in multiple-day regimens is not effective and uses a different type of medication for breakthrough emesis, thus decreasing the utility of this as an effective control group.

Palonosetron demonstrates effective prevention of acute CINV in the setting of multiple-day chemotherapy regimens and treatment of breakthrough emesis when repeated 72 hours after the initial dose.

Patients with malignant melanoma received paroxetine or a placebo two weeks prior to initiation of interferon alfa, continuing for the first 12 weeks of therapy. Study tablets contained 10 mg paroxetine; both groups took one tablet daily for a week, followed by 2 tablets daily for a week. Two weeks after the initiation of interferon alfa (four weeks after beginning paroxetine or placebo), the dosage of the study medication could be increased up to four tablets per day at the discretion of the study psychiatrist. The average number of tablets at the maximal dose for each group was 3.1. Patients were evaluated at baseline and at regularly scheduled intervals for the first 12 weeks of therapy.

40 adult patients with malignant melanoma that had been resected but was estimated to have a greater than 50% chance of recurrence

Single site

Randomized, double-blind study

• Hamilton Rating Scale for Depression
• Carroll Rating Scale for Depression
• Hamilton Rating Scale for Anxiety
• Neurotoxicity Scale

• Major depression symptoms developed in 2 of 18 patients (11%) in the paroxetine group  and 9 of 20 (45%) in the placebo group.
• Paroxetine treatment significantly decreased the likelihood that interferon alfa therapy would have to be discontinued because of severe depression.

The sample size was small. One disease group and one site were involved in the study.

To determine the effects of a spiritual care and support program on levels of depression in patients with leukemia

Patients in intensive care randomly were assigned to the spiritual care or control groups. Patients in the control group could receive the spiritual care program after the completion of the study. The program encouraged a supportive presence through the expression of feelings, needs, and concerns, and provided education regarding disease, treatment, and supportive touch. To support religious rituals, patients were provided a prayer rug, rosary, and a veil for women. Participants also had access to an MP3 player and earphones to listen to prayers and passages from the Quran. Readings of prayers and the Quran at the bedside were implemented by a clergyman. Study measures were obtained at baseline and on day 3 by an individual blinded to study group assignment.

• N = 64  
• MEAN AGE = 41.68 years
• MALES: 60.5%, FEMALES: 39.5%
• KEY DISEASE CHARACTERISTICS: All participants were diagnosed with leukemia, and most participants had acute myeloid leukemia.
• OTHER KEY SAMPLE CHARACTERISTICS: About 50% of participants had a high school education. The mean time since diagnosis was 24.32 months in the experimental group and 18.08 months in the control group.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Iran

• PHASE OF CARE: Active antitumor treatment

Single-blinded, randomized, controlled trial

• Depression Anxiety and Stress Scale (DASS)

The mean postintervention score in the experimental group was lower than that of the control group (p < .001), and the change in depression scores in the intervention group was marginally significant (p < .07). Baseline data and changes for both groups were not provided.

This intervention, which included support and psychoeducational components along with spiritual support, was associated with reduced depression scores.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: Findings may not be applicable to other cultural groups and individuals. The study had a very short duration. The treatment involved was not described, so it is not clear whether some patients were more acutely ill than others.

Supportive and psychoeducational interventions that include a component of spiritual support may be beneficial for hospitalized patients with leukemia. The provision of holistic supportive care is a principle of nursing care. These findings provide marginal support for the efficacy of these interventions during short-term hospitalization. There were several study limitations.

The objective of the study was to retrospectively examine whether recurrent malignant pleural effusions (MPEs) could be managed on an outpatient basis using small-bore tunneled pleural catheters (PCs) and without the use of sclerosing agents.

The study was a retrospective analysis of 24 patients who underwent placement of PCs to manage recurrent dyspnea symptoms due to MPEs.

Patients chosen were experiencing symptomatic MPEs and

• Had an advanced primary malignancy
• Had a predicted life expectancy of at least three months
• Had prior experience with dyspnea symptom relief post-thoracentesis
• Had radiographic evidence of an accessible, free-flowing pleural effusion.

PC placement took place in an outpatient clinic under local anesthesia or conscious sedation. Written and oral instructions were given to the patients and caregivers, including details on how to care for the catheter and perform drainage at home. Patients and their caregivers also received home visits from a home health nurse to reinforce these instructions. Patients were evaluated in the outpatient center weekly for the first two weeks and then as needed clinically. In each post-placement visit, patients were evaluated for subjective findings such as dyspnea, chest discomfort, and exercise intolerance. Objective evaluations included pulse oximetry, blood pressure, heart rate, respiratory rate, and weight measurement. In addition, patients were evaluated for pulmonary and/or catheter complications, including chest radiographs and computed tomography scans (if indicated).

Once the PC output was less than 50 mL on three consecutive days, the PC was removed using only local anesthesia in the Pulmonary Outpatient Center, and patients were periodically followed by the Interventional Pulmonology outpatient practice for evaluation of symptom recurrence or effusion.

• The study reported on a sample of 24 patients aged 47–89 years.
• Of the sample, 33% were males and 67% were females.
• Key disease characteristics were breast (11), lung (5), colon (1), mesothelioma (3), renal (1), melanoma (1), and adenocarcinoma of unknown primary (2).
• Patients who were extremely ill and had the potential to be admitted for the treatment of MPEs were excluded from this study.
   

This single-site study was conducted in an outpatient clinic in Philadelphia, PA, for both insertion and removal of the PC catheter.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for end of life, palliative care, and quality of life . 
   

The study was a retrospective chart analysis.

The dyspnea assessment instrument was not identified, but the presence and absence of dyspnea was implied.

A total of 27 PCs were placed. Three patients had bilateral PC placement, and one patient had two ipsilateral catheter placements (accounting for the extra catheter placements). All catheters were placed in an outpatient setting, and patients were sent home on the same day without any immediate complications. Five patients died during the study; four of these patients had fully functioning and patent catheters. The fifth patient developed cardiac tamponade, and the PC was removed and replaced by a chest tube. The indwelling time for these five patients prior to passing was 26.3 days.

Complications related to catheter placement included cellulitis, bacterial super-infection, and incisional tumor growth. These complications were managed with antibiotics, removal of the PC, and increases in anti-neoplastic medication.

Nineteen patients survived to catheter removal or to the time the analysis took place. Out of the 19 patients, 10 patients reached spontaneous pleurodesis after using daily PC drainage over a median time of 39 days. One patient achieved pleurodesis in 15 days after PC placement for a total of 11 out of 19 (58%) patients achieving either complete or partial pleurodesis without chest tubes or the use of sclerosing agents.

Small-bore tunneled pleural catheters are offered as an alternative, more palliative, less invasive treatment for MPEs. The number of patients in this study that reported relief of dyspnea symptoms and were able to achieve complete or partial pleurodesis after PC placement is comparable to those who undergo more invasive procedures.

•  The study had no appropriate control group
•  The study had a small sample size.
• The authors themselves recognized the potential bias of the study by excluding those patients who were extremely ill with a significant risk of being admitted for the management of MPEs.

The outpatient small-bore tunneled catheter method does not seem to be an appropriate method for patients with recurrent, symptomatic MPEs  who have weeks or days to live.

STUDY PURPOSE: To evaluate the current literature related to the efficacy and safety of tranexamic acid in craniomaxillofacial, head and neck, breast, aesthetic, burns, and plastic surgery

• FINAL NUMBER STUDIES INCLUDED = 14 studies included, 7 for meta-analysis (head and neck and breast not included in meta-analysis)
• TOTAL PATIENTS INCLUDED IN REVIEW = 288 for meta-analysis
• SAMPLE RANGE ACROSS STUDIES: Of the total studies considered, 14, including 908 patients, met inclusion criteria. Of those in this group, subspecialties included craniofacial, orthognathic, head and neck, breast, and aesthetic surgery.
• KEY SAMPLE CHARACTERISTICS: Four trials for craniofacial and three trials for orthognathic surgery

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Pediatrics

In the craniofacial studies, tranexamic acid use led to reduced blood loss (p = 0.00001) and a reduction in transfusion requirements (p = 0.00001). In the orthognathic studies, tranexamic acid use led to reduced blood loss (p = 0.01). In the head and neck trial, tranexamic acid led to a reduction in mean volume of drainage (p = 0.041). In the breast trial, tranexamic acid led to a reduction in drainage volume (p < 0.001). No complications were reported with the use of tranexamic acid in any of the included trials.

Tranexamic acid reduces blood loss and reduces the need for blood transfusions in craniofacial surgery. It reduces blood loss in orthognathic surgery and may reduce the drainage volumes in head and neck and breast surgeries.

• Limited number of studies included
• Mostly low quality/high risk of bias studies
• The head and neck study was underpowered.
• The breast trial’s protocol was not described well, with risk of bias.  
• Other agents used (ESA), other management strategies (blood pressure control, positional strategies), dosing differences, and so forth

Nurses involved in the surgical management of patients with cancer could consider the benefits of tranexamic acid in reducing drainage volumes in patients with head and neck or breast cancer. However, the articles did not draw clear correlations with the type of surgery and the presence of cancer. No significant finding was reported in these two populations related to the prevention of bleeding during or following surgical procedures.