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Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery

 Jae Hyup Lee  ;  Jin-Hyok Kim  ;  Jin-Hwan Kim  ;  Hak-Sun Kim  ;  Woo-Kie Min  ;  Ye-Soo Park  ;  Kyu-Yeol Lee  ;  Jung-Hee Lee 
 Pain Research & Management, Vol.2017 : 2071494, 2017 
Journal Title
 Pain Research & Management 
Issue Date
Acetaminophen/administration & dosage ; Acetaminophen/therapeutic use* ; Administration, Cutaneous ; Aged ; Analgesics, Opioid/administration & dosage ; Analgesics, Opioid/therapeutic use ; Buprenorphine/administration & dosage ; Buprenorphine/therapeutic use* ; Female ; Humans ; Male ; Middle Aged ; Pain, Postoperative/drug therapy* ; Quality of Life ; Spine/surgery* ; Tramadol/administration & dosage ; Tramadol/therapeutic use*
PURPOSE: Control of persistent pain following spinal surgery is an unmet clinical need. This study compared the efficacy and safety of buprenorphine transdermal system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with persistent, moderate pain following spinal surgery. METHODS: Open-label, interventional, randomized multicenter study. Adults with persistent postoperative pain (Numeric Rating Scale [NRS] ≥ 4 at 14-90 days postsurgery) were enrolled. Patients received once-weekly BTDS (n = 47; 5 μg/h titrated to 20 μg/h) or twice-daily TA (n = 40; tramadol 37.5 mg/acetaminophen 325 mg, one tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, medication compliance, and adverse events (AEs) were assessed. FINDINGS: At week 6, both groups reported significant pain reduction (mean NRS change: BTDS -2.02; TA -2.76, both P < 0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; TA 0.19, both P < 0.05). The BTDS group achieved better medication compliance (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug reactions (20.3% versus 16.9%) were comparable between groups. IMPLICATIONS: For patients with persistent pain following spinal surgery, BTDS is an alternative to TA for reducing pain and supports medication compliance. This trial is registered with Clinicaltrials.gov: NCT01983111.
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1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실)
Yonsei Authors
김학선(Kim, Hak Sun)
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