Conversion from high-dose full-opioid agonists to sublingual buprenorphine reduces pain scores and improves quality of life for chronic pain patients.

OBJECTIVE: This study aims to determine the effectiveness of converting patients from high doses of full-opioid agonists to sublingual (SL) buprenorphine. DESIGN: An observational report of outcomes assessment. SETTING: An interventional pain management practice setting in the United States. SUBJECTS: Thirty-five chronic pain patients (age 24-66) were previously treated with high-dose opioid-agonist drugs and converted to SL buprenorphine. Patients' daily morphine equivalents ranged from 200 mg to 1,370 mg preconversion, with a mean daily dose of 550 mg. METHODS: A retrospective chart analysis examined numerical pain levels and quality of life scores before and 2 months after conversion to SL buprenorphine. RESULTS: After continuation of SL buprenorphine therapy for 2 months, the mean pain score decreased from 7.2 to 3.5 (P < 0.001), with 34 of the 35 patients examined reporting a decrease in pain. This pain score decrease was robust with regard to initial pain score and preconversion morphine equivalent dosage. Quality of life scores improved from 6.1 to 7.1 (P = 0.005). CONCLUSION: Average pain scores decreased from 7.2 to 3.5, and quality of life scores increased from 6.1 to 7.1 for 35 patients converted from high-dose full-opioid agonists to SL buprenorphine therapy for more than 60 days. Clinicians should consider buprenorphine SL conversion for all patients on high-dose opioids, particularly patients with severe pain (7-10) unrelieved by their current opioid regimen or patients for whom the clinician does not feel comfortable prescribing high-dose opioids.

Conversion of chronic pain patients from full-opioid agonists to sublingual buprenorphine.

BACKGROUND: Sublingual buprenorphine-naloxone (buprenorphine SL) is a preparation that is used to treat opioid dependence. In addition, the Drug Enforcement Administration (DEA) has acknowledged the legality of an off-label use to treat pain with a sublingual buprenorphine preparation. Buprenorphine SL is unique among the opioid class of analgesics; this compound has a high affinity for the mu-receptor, yet only partially activates it. Thus, buprenorphine SL can provide analgesia, yet minimize opioid side effects. Many patients on high doses of traditional opioid medication develop tolerance. Despite escalating medication dosage, a subset of patients had a paradoxical increase in pain, which has been characterized as opioid-induced hyperalgesia (OIH).  Buprenorphine SL, on the other hand, may even be anti-hyperalgesic and may have utility in treating these challenging patients. OBJECTIVE: To determine the effectiveness of converting patients from traditional full agonist opioid medication to sublingual buprenorphine, as well as to identify patient groups that are most likely to benefit from this therapy. Patients who underwent conversion either had developed tolerance with diminished analgesia or were experiencing side effects on their opioid medications. STUDY DESIGN: An observational report of outcomes assessment. SETTING: An interventional pain management practice setting in the United States. METHODS: Retrospective data from clinical records was compiled on 104 de-identified chronic pain patients whose personal information had been redacted (60 men and 44 women, aged 21-78) and who had previously been treated with opioid-agonist drugs; they were converted to buprenorphine SL in tablet form during the study. Chronic pain was defined as persistent pain for at least 6 months. Data collected from patient profiles included age, sex, diagnosis, medication history, pre-induction opioid intake, reason for detoxification, pre-induction Clinical Opiate Withdrawal Score (COWS), and if applicable, cause of buprenorphine SL cessation. Pain levels and Quality of Life scores were recorded before and after conversion to buprenorphine SL. OUTCOME MEASURES: Level of analgesia for patients who continued conversion to sublingual buprenorphine for more than 2 months. RESULTS: After initiation of buprenorphine SL therapy for more than 2 months, the mean pain scores on a scale from 0-10 decreased by 2.3 points (P < 0.001). Patient Quality of Life (QoL scale) was not significantly affected by buprenorphine SL therapy (P = 0.14). The success rate was highest for patients using morphine, oxycodone, and fentanyl before buprenorphine SL induction. These patient groups had a 3.7 point decrease in pain for those taking morphine, a 2.5 point decrease in pain for those taking oxycodone, and a 2.2 point decrease for those taking fentanyl. The smallest pain reduction was seen in the patient group using oxymorphone before conversion with a 1.1 point decrease in pain. Patients taking between 100-199 mg morphine equivalent per day experienced the greatest reduction (2.7 points) in pain scores. Patients taking between 200 and 299 mg morphine equivalent before buprenorphine SL induction exhibited a decrease of over 2 points on average. Patients taking > 400 mg morphine equivalent reported the smallest reduction in pain scores, on average a 1.1 point decrease. LIMITATIONS: This study is limited by its observational nature. CONCLUSIONS: Patients continuing buprenorphine SL therapy for more than 60 days reported significant decreases in pain (2.3 points). Patients on doses of opioid medication between 100-199 mg morphine equivalents seemed to fare better with conversion to buprenorphine SL than patients on the highest doses (> 400 mg morphine equivalents). The opioid drug used by the patient before buprenorphine SL induction appears to have some effect on buprenorphine SL conversion success. Patients previously taking morphine, oxycodone, and fentanyl had the greatest decrease in pain after conversion to buprenorphine SL.

Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study.

BACKGROUND CONTEXT: Sacral insufficiency fractures (SIFs) can cause low back pain in osteoporotic patients. Symptomatic improvement may require up to 12 months. Treatment includes limited weightbearing and bed rest, oral analgesics, and sacral corsets. Significant mortality and morbidity are associated with pelvic insufficiency fractures. Percutaneous injection of polymethylmethacrylate (PMMA) into the fractured ala, sacroplasty, is an alternative treatment for SIF patients. Under fluoroscopic control, 13-G bone trochars are inserted into the fractured ala while the patient is maintained under conscious sedation. Initial reports have documented safe and effective performance of sacroplasty. Yet, these uncontrolled findings do not allow any precision in estimating complication rates or expected outcome. PURPOSE: Assess rates of complications and observe outcomes after sacroplasty in a medium-sized uncontrolled cohort of SIF patients. STUDY DESIGN/SETTING: A prospective observational cohort study of consecutive osteoporotic SIF patients. PATIENT SAMPLE: Consecutive, osteoporotic patients with symptomatic SIFs electing to enter the study. OUTCOME MEASURES: Visual Analogue Scale (VAS) score, analgesic utilization, and patient satisfaction. METHODS: Baseline VAS rating, analgesic usage, and duration of symptoms were recorded. Subsequent VAS ratings were assessed within 30 minutes after the procedure, at 2-, 4-, 12-, 24-, and 52-week postprocedure. Analgesic usage and patient satisfaction were assessed at final follow-up. Each procedure was performed under light intravenous conscious sedation using fluoroscopy. Two bone trochars were inserted between the sacral foramen and sacroiliac joint through which 2 to 3 cc of PMMA were injected. RESULTS: Fifty-two patients, 40 females, were treated. The mean age was 75.9 years with a mean symptom duration of 34.5 days. All patients were available at each follow-up interval except one patient who died because of unrelated pulmonary disease before the 4-week follow-up. The mean VAS score at baseline was 8.1 and 3.4 within 30 minutes after the procedure, 2.5 at 2, 2.1 at 4, 1.7 at 12, 1.4 at 24, and 0.8 at 52 weeks. Improvement was statistically significant using a repeated measures single-factor analysis of variance. One case of transient S1 radiculitis occurred but resolved completely with one transforaminal epidural steroid injection. CONCLUSIONS: Sacroplasty for SIF appears to be associated with rapid and sustained pain relief in most patients with few complications. More rigorous trials are warranted to provide definitive evidence of the safety and efficacy of sacroplasty for SIFs.

Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures: a prospective, multicenter trial.

STUDY DESIGN: A prospective observational cohort study of consecutive osteoporotic patients with sacral insufficiency fractures (SIFs). OBJECTIVE: Assess the safety and efficacy of sacroplasty in treating osteoporotic SIFs. SUMMARY OF BACKGROUND DATA: SIFs can cause low back pain in osteoporotic patients. Symptomatic improvement may require up to 12 months. Treatment includes limited weight-bearing and bed rest, oral analgesics, and sacral corsets. Significant mortality and morbidity are associated with pelvic insufficiency fractures. Percutaneous sacroplasty is an alternative treatment for SIF patients, and initial reports have documented its safe and effective performance. Yet, follow-up intervals have been short, and study cohorts small precluding definitive assessment of sacroplasty's safety and efficacy. METHODS: Baseline Visual Analogue Scale (VAS), analgesic usage, and duration of symptoms were recorded. Subsequent VAS ratings were assessed at 30 minutes and at 2, 4, 12, 24, and 52 weeks postprocedure. Analgesic usage and patient satisfaction were assessed at final follow-up. Each procedure was performed under intravenous conscious sedation using fluoroscopy. Two bone trochars were inserted between the sacral foramen and sacroiliac joint through which 2 to 3 mL of polymethylmethacrylate was injected. RESULTS: Thirty-seven patients, 27 females, were treated. Mean age was 76.6 years, and mean symptom duration was 34.4 days. All patients were available at each follow-up interval except 1 patient who died due to unrelated pulmonary disease before the 4-week follow-up. The mean VAS score at baseline was 7.7 and 3.2 within 30 minutes, and 2.1 at 2, 1.7 at 4, 1.3 at 12, 1.0 at 24, and 0.7 at 52 weeks postprocedure. Improvement at each interval and overall was statistically significant using the Wilcoxon Rank Sum Test. One case of transient S1 radiculitis was encountered. CONCLUSIONS: Sacroplasty appears to be a safe and effective treatment for painful SIF. The rate of improvement is rapid and sustained through 1 year.