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Comparison between ultrasound-guided multi-injection intertransverse process and thoracic paravertebral blocks for major breast cancer surgery: a randomized non-inferiority trial
  1. Hongye Zhang1,
  2. Zongyang Qu1,
  3. Yongsheng Miao1,
  4. Yuelun Zhang2,
  5. Lulu Qian1,
  6. Bin Hua3 and
  7. Zhen Hua1
  1. 1Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China
  2. 2Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
  3. 3Breast Center, Department of Thyroid-Breast-Hernia Surgery, Department of General Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China
  1. Correspondence to Dr Lulu Qian, Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing 100730, China; 560427qll{at}163.com

Abstract

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
  • analgesia
  • pain, postoperative
  • regional anesthesia

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

  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.