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.
Hannah Wells, Krisha Malik, Penelope M A Brasher, Esta Bovill, Nancy Van Laeken, Rebecca Warburton, Christopher Prabhakar, Xi Lisa Li, Kathryn V Isaac
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引用次数: 0
Abstract
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.
期刊介绍:
The Canadian Journal of Anesthesia (the Journal) is owned by the Canadian Anesthesiologists’
Society and is published by Springer Science + Business Media, LLM (New York). From the
first year of publication in 1954, the international exposure of the Journal has broadened
considerably, with articles now received from over 50 countries. The Journal is published
monthly, and has an impact Factor (mean journal citation frequency) of 2.127 (in 2012). Article
types consist of invited editorials, reports of original investigations (clinical and basic sciences
articles), case reports/case series, review articles, systematic reviews, accredited continuing
professional development (CPD) modules, and Letters to the Editor. The editorial content,
according to the mission statement, spans the fields of anesthesia, acute and chronic pain,
perioperative medicine and critical care. In addition, the Journal publishes practice guidelines
and standards articles relevant to clinicians. Articles are published either in English or in French,
according to the language of submission.