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Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial

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Abstract

Purpose

To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery.

Methods

The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points.

Results

The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups.

Conclusions

The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

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Authors and Affiliations

  1. Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, 166 Gumiro, Bundang-gu, Sungnam, 463-707, Republic of Korea

    Ho-Joong Kim, Hyo Sae Ahn, Yunjin Nam & Jin S. Yeom

  2. Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Hospital, 101 Daehangno, Jongno-gu, Seoul, 110-744, Republic of Korea

    Bong-Soon Chang & Choon-Ki Lee

Authors
  1. Ho-Joong Kim
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  2. Hyo Sae Ahn
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  6. Jin S. Yeom
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Corresponding author

Correspondence to Jin S. Yeom.

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Funding

This study was partially supported by research Grants from Mundipharma Co. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflict of interest

None of the authors has any potential conflict of interest.

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Kim, HJ., Ahn, H.S., Nam, Y. et al. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J 26, 2961–2968 (2017). https://doi.org/10.1007/s00586-017-5213-5

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  • DOI: https://doi.org/10.1007/s00586-017-5213-5

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