Background This study investigated whether a novel multi-injection intertransverse process block could provide non-inferior analgesia and recovery quality following major breast cancer surgery compared with the multi-injection thoracic paravertebral block.
Methods Eighty-eight females who underwent mastectomy plus sentinel or axillary lymph node dissection were randomized to receive either intertransverse process block or thoracic paravertebral block, both performed at T2–6 with 5 mL of 0.5% ropivacaine per level. The primary outcome was the worst resting pain score (11-point Numerical Rating Scale) within 30 min in the recovery room. The secondary outcome was recovery quality (15-item quality of recovery scale) 24 hours after surgery, which was tested following a gatekeeping procedure.
Results The worst resting pain scores were 0 (0, 1) in the intertransverse process block group vs 0.5 (0, 2) in the thoracic paravertebral block group, with a median difference of 0 (95% CI 0 to 0); the upper 95% CI limit was lower than the prespecified non-inferiority margin of 1 point (non-inferiority p<0.001). Aggregate scores of recovery quality at 24 hours postoperatively were 137.5 (126.5, 142.8) and 137.5 (127.8, 145.0) for the intertransverse process and thoracic paravertebral block groups, respectively, with a median difference of −1 (95% CI −6 to 3); the lower 95% CI limit was larger than the prespecified non-inferiority margin of −8 (non-inferiority p=0.006).
Conclusions Compared with a multi-injection thoracic paravertebral block, the multi-injection intertransverse process block provided non-inferior analgesia within 30 min in the recovery room and recovery quality at 24 hours following major breast cancer surgery in females.
Trial registration number ChiCTR2000037963.
- anesthesia, local
- pain, postoperative
- regional anesthesia
Data availability statement
Data are available on reasonable request.
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Contributors HZ and LQ are responsible for the overall content as guarantors. We accept full responsibility for the finished work and/or the conduct of the study. HZ: Study design, planning and conduct, data interpretation and critical revision of the manuscript. ZQ: Study design, data collection, data analysis and interpretation. YM: Recruitment of patients and data collection. YZ: Data analysis, data interpretation and manuscript revision. LQ: Study design, planning and conduct, data collection and manuscript drafting. BH: Recruitment of patients. ZH: Data collection and manuscript revision.
Funding This work was supported by National High Level Hospital Clinical Research Funding (No. BJ-2022-136).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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