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Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol.
Medicine (Baltimore). 2020 Jun 12; 99(24):e20405.M

Abstract

BACKGROUND

The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty.

METHODS

This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction.

RESULTS

This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome.

TRIAL REGISTRATION NUMBER

This study protocol was registered in Research Registry (researchregistry5524).

Authors+Show Affiliations

Department of Medicine, Linyi Cancer Hospital.Department of Orthopedics, Yinan County Hospital of Traditional Chinese Medicine.Department of Orthopedics, Linyi Cancer Hospital, Shandong, China.Department of Medicine, Linyi Cancer Hospital.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32541462

Citation

Li, Wen-Min, et al. "Analgesic Impact of Buprenorphine Transdermal Patch in Total Hip Arthroplasty: a Randomized Controlled Trial Protocol." Medicine, vol. 99, no. 24, 2020, pp. e20405.
Li WM, Li FD, Xu H, et al. Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol. Medicine (Baltimore). 2020;99(24):e20405.
Li, W. M., Li, F. D., Xu, H., & Sun, L. C. (2020). Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol. Medicine, 99(24), e20405. https://doi.org/10.1097/MD.0000000000020405
Li WM, et al. Analgesic Impact of Buprenorphine Transdermal Patch in Total Hip Arthroplasty: a Randomized Controlled Trial Protocol. Medicine (Baltimore). 2020 Jun 12;99(24):e20405. PubMed PMID: 32541462.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol. AU - Li,Wen-Min, AU - Li,Feng-Dao, AU - Xu,Hua, AU - Sun,Li-Chen, PY - 2020/6/17/entrez PY - 2020/6/17/pubmed PY - 2020/6/17/medline SP - e20405 EP - e20405 JF - Medicine JO - Medicine (Baltimore) VL - 99 IS - 24 N2 - BACKGROUND: The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty. METHODS: This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction. RESULTS: This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome. TRIAL REGISTRATION NUMBER: This study protocol was registered in Research Registry (researchregistry5524). SN - 1536-5964 UR - https://www.unboundmedicine.com/medline/citation/32541462/Analgesic_impact_of_buprenorphine_transdermal_patch_in_total_hip_arthroplasty:_A_randomized_controlled_trial_protocol L2 - https://doi.org/10.1097/MD.0000000000020405 DB - PRIME DP - Unbound Medicine ER -