Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery
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...
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| Format: | Article |
| Language: | English |
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Wiley
2017-01-01
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| Series: | Pain Research and Management |
| Online Access: | http://dx.doi.org/10.1155/2017/2071494 |
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| author | Jae Hyup Lee Jin-Hyok Kim Jin-Hwan Kim Hak-Sun Kim Woo-Kie Min Ye-Soo Park Kyu-Yeol Lee Jung-Hee Lee |
| author_facet | Jae Hyup Lee Jin-Hyok Kim Jin-Hwan Kim Hak-Sun Kim Woo-Kie Min Ye-Soo Park Kyu-Yeol Lee Jung-Hee Lee |
| author_sort | Jae Hyup Lee |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-440f64be9f2b4640b7b794ce5a10caf4 |
| institution | Kabale University |
| issn | 1203-6765 1918-1523 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pain Research and Management |
| spelling | doaj-art-440f64be9f2b4640b7b794ce5a10caf42025-02-03T05:54:11ZengWileyPain Research and Management1203-67651918-15232017-01-01201710.1155/2017/20714942071494Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal SurgeryJae Hyup Lee0Jin-Hyok Kim1Jin-Hwan Kim2Hak-Sun Kim3Woo-Kie Min4Ye-Soo Park5Kyu-Yeol Lee6Jung-Hee Lee7Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of KoreaDepartment of Orthopedic Surgery, Sanggye Paik Hospital, Seoul, Republic of KoreaDepartment of Orthopedic Surgery, Ilsan Paik Hospital, Gyeonggi-do, Republic of KoreaDepartment of Orthopedic Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of KoreaDepartment of Orthopedic Surgery, Kyungpook National University Hospital, Daegu, Republic of KoreaDepartment of Orthopedic Surgery, Guri Hospital, Hanyang University College of Medicine, Gyeonggi-do, Republic of KoreaDepartment of Orthopedic Surgery, Dong-A University Hospital, Busan, Republic of KoreaDepartment of Orthopedic Surgery, Graduate School, College of Medicine, Kyung Hee University, Seoul, Republic of KoreaPurpose. 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.http://dx.doi.org/10.1155/2017/2071494 |
| spellingShingle | Jae Hyup Lee Jin-Hyok Kim Jin-Hwan Kim Hak-Sun Kim Woo-Kie Min Ye-Soo Park Kyu-Yeol Lee Jung-Hee Lee Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery Pain Research and Management |
| title | Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery |
| title_full | Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery |
| title_fullStr | Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery |
| title_full_unstemmed | Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery |
| title_short | Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery |
| title_sort | efficacy and safety of transdermal buprenorphine versus oral tramadol acetaminophen in patients with persistent postoperative pain after spinal surgery |
| url | http://dx.doi.org/10.1155/2017/2071494 |
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