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Purpose <p>Postmastectomy breast reconstruction (BR) may be associated with significant postoperative pain. Use of regional anesthetic blocks has been identified as a potentially beneficial technique to reduce perioperative pain. We sought to conduct a pilot feasibility trial to evaluate the addition of interpectoral and pectoserratus blocks to thoracic paravertebral blocks (TPVBs).</p> Methods <p>We conducted a pilot feasibility randomized controlled trial (RCT) at the Providence Breast Centre (Mount Saint Joseph’s Hospital, Vancouver, BC, Canada), between 7 May 2021 and 17 March 2023. Adult female patients undergoing BR using tissue expanders or implants were randomized (1:1) to receive TPVB + interpectoral and pectoserratus blocks (intervention) or TPVB + saline (control). Feasibility outcomes related to recruitment, retention, block administration, and safety. We also measured numerical rating scale (NRS) pain scores 24&#xa0;hr postoperatively and assessed whether the lower bound of the 80% confidence interval (CI) for the between-group difference in mean scores was &gt; 0.</p> Results <p>Of 83 eligible patients, 30 (36%) were randomized. Average recruitment was 1.3 patients per month; all blocks were successfully administered, and there were no complications associated with the blocks. Retention to the end of follow-up (six months) was 90%. Mean (standard deviation) self-reported NRS pain scores at 24&#xa0;hr postoperatively were 3.0 (1.9) and 3.5 (1.9) in the control and intervention groups, respectively (difference in means, −0.5; 80% confidence interval, −1.4 to 0.5).</p> Conclusion <p>This RCT showed the feasibility and safety of the intervention with a high retention to the end of follow-up. Nevertheless, we did not meet our prespecified recruitment target, and the results did not provide evidence of potential effectiveness of the intervention to sufficiently support the conduct of a definitive efficacy RCT.</p> Study registration <p>ClinicalTrials.gov (<a href="https://clinicaltrials.gov/study/NCT04860843?term=NCT04860843&amp;rank=1">NCT04860843</a>); first posted 27 April 2021.</p>

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The addition of interpectoral and pectoserratus fascial plane blocks to paravertebral blocks for analgesia after total mastectomy and immediate breast reconstruction: a pilot feasibility randomized controlled trial

  • 期刊论文

  • 发表日期：

    2025年9月22日

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  • Hannah Wells,
  • Krisha Malik,
  • Penelope M. A. Brasher,
  • Esta Bovill,
  • Nancy Van Laeken,
  • Rebecca Warburton,
  • Christopher Prabhakar,
  • Xi Lisa Li,
  • Kathryn V. Isaac

摘要

Purpose

Postmastectomy breast reconstruction (BR) may be associated with significant postoperative pain. Use of regional anesthetic blocks has been identified as a potentially beneficial technique to reduce perioperative pain. We sought to conduct a pilot feasibility trial to evaluate the addition of interpectoral and pectoserratus blocks to thoracic paravertebral blocks (TPVBs).

Methods

We conducted a pilot feasibility randomized controlled trial (RCT) at the Providence Breast Centre (Mount Saint Joseph’s Hospital, Vancouver, BC, Canada), between 7 May 2021 and 17 March 2023. Adult female patients undergoing BR using tissue expanders or implants were randomized (1:1) to receive TPVB + interpectoral and pectoserratus blocks (intervention) or TPVB + saline (control). Feasibility outcomes related to recruitment, retention, block administration, and safety. We also measured numerical rating scale (NRS) pain scores 24 hr postoperatively and assessed whether the lower bound of the 80% confidence interval (CI) for the between-group difference in mean scores was > 0.

Results

Of 83 eligible patients, 30 (36%) were randomized. Average recruitment was 1.3 patients per month; all blocks were successfully administered, and there were no complications associated with the blocks. Retention to the end of follow-up (six months) was 90%. Mean (standard deviation) self-reported NRS pain scores at 24 hr postoperatively were 3.0 (1.9) and 3.5 (1.9) in the control and intervention groups, respectively (difference in means, −0.5; 80% confidence interval, −1.4 to 0.5).

Conclusion

This RCT showed the feasibility and safety of the intervention with a high retention to the end of follow-up. Nevertheless, we did not meet our prespecified recruitment target, and the results did not provide evidence of potential effectiveness of the intervention to sufficiently support the conduct of a definitive efficacy RCT.

Study registration

ClinicalTrials.gov (NCT04860843); first posted 27 April 2021.