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Insignificant influence of the intertransverse process block for major breast cancer surgery: a randomized, blinded, placebo-controlled, clinical trial
  1. Martin Vedel Nielsen1,
  2. Katrine Tanggaard1,
  3. Lone Bak Hansen2,
  4. Christian Kruse Hansen1,
  5. Mojgan Vazin1 and
  6. Jens Børglum1,3
  1. 1Department of Anesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, Denmark
  2. 2Department of Plastic Surgery and Breast Surgery, Zealand University Hospital, Roskilde, Denmark
  3. 3Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark
  1. Correspondence to Dr Martin Vedel Nielsen, Department of Anesthesiology and Intensive Care Medicine, Zealand University Hospital Roskilde, Roskilde 4000, Denmark; martinvedel{at}gmail.com

Abstract

Introduction The intertransverse process (ITP) block mimics the thoracic paravertebral block and allegedly ameliorates hemithoracic postoperative pain. However, concerning major reconstructive breast cancer surgery the modality has never been tested against placebo in a randomized clinical trial. We aimed to assess the efficacy of the multiple-injection ITP block and hypothesized that the blockade would reduce postoperative opioid consumption.

Methods We screened 58 patients with breast cancer scheduled for unilateral subpectoral implant-based primary breast reconstruction, involving mastectomy with complete fascial dissection of the major pectoral muscle. A randomization procedure allowed for the allocation of 36 patients to receive either unilateral multiple-injection active ITP block (0.5% ropivacaine 3×10 mL) or placebo ITP block (isotonic saline 3×10 mL) at T2, T4, T6 in a prospective, blinded, clinical trial. The primary outcome was total opioid consumption within the first 24 postoperative hours. Secondary outcomes included opioid consumption at 4-hour intervals, postoperative pain, patient satisfaction with block application, time to first opioid, ambulation and discharge, opioid-related side effects, and quality of recovery.

Results Opioid consumption within the first 24 postoperative hours showed no significant reduction when comparing the active and placebo group median (IQR): 75.0 mg (45–135) vs 62.5 mg (30–115), p=0.5, respectively. We did not find any consequential clinically relevant results of the secondary outcomes.

Conclusions Following major reconstructive breast cancer surgery, a preoperative multiple-injection ITP block neither reduces 24-hour opioid consumption postoperatively nor promotes substantial clinical positive outcomes.

Trial registration number EudraCT2019-001016-35.

  • pain, postoperative
  • ultrasonography
  • regional anesthesia
  • treatment outcome
  • nerve block

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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Footnotes

  • Twitter @JensBorglum

  • Contributors MVN: planning, designing, conducting, acquisition of data, analyzing data, reporting, interpreting data, and writing the manuscript. KT/LBH/CH/MVK: conducting, interpreting data, and writing the manuscript. JB: planning, designing, conducting, acquisition of data, analyzing data, reporting, interpreting data, and writing the manuscript. MVN stands as guarantor for the overall content.

  • Funding MVN has received a donation from Region Zealand Health Science Foundation.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.