Trial reportCanadian journal of anaesthesia = Journal canadien d'anesthesie2025
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.
Trial report in Canadian journal of anaesthesia = Journal canadien d'anesthesie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04860843 (Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePostmastectomy 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).
methodsWe 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.
resultsOf 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).
conclusionThis 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.
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