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Noninferiority of Ultrasound-Guided Modified Intercostal Block to Traditional Approach for Analgesia After Minimally
Ming-Wen Yang1,2, Xian-Lun Duan3, Yu-Zhu Cai2
1Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230000, Anhui, China, ahtcm.edu.cn.
Background:
For pediatric pectus excavatum, the standard treatment is minimally invasive repair of pectus excavatum (MIRPE). A major challenge, however, is the severe postoperative pain. Although ultrasound-guided intercostal nerve block (UINB) offers effective analgesia, the technique's complexity and associated safety concerns are significant barriers, deterring its routine use. Modified intercostal nerve block (MINB) is effective in adult thoracic surgery but unvalidated in pediatric MIRPE.
Objective:
To evaluate MINB's noninferiority to UINB for postoperative analgesia and safety in children undergoing MIRPE.
Design:
Single-center randomized noninferiority trial.
Methods:
Seventy-six ASA I-II pediatric patients (8-18 years) scheduled for single-bar MIRPE were 1:1 randomized to the MINB or UINB group. Primary outcome includes 24-h postoperative coughing visual analog scale (VAS) score (noninferiority margin Δ = 1.0). Secondary outcomes include resting/coughing VAS scores at 3, 6, 9, 12, 24, and 48 h postoperatively; procedure duration; local anesthetic dose; needle complications; opioid consumption; rescue analgesia; and adverse events.
Results:
The mean difference in 24-h coughing VAS (MINB-UINB) score was -0.02 (95% CI: -0.85 to 0.80), confirming noninferiority of MINB (upper 95% CI limit 0.80 < noninferiority margin Δ = 1.0). MINB reduced procedure time by 65% (4.6 ± 1.3 vs. 13.2 ± 1.6 min; p < 0.001), decreased ropivacaine dose by 19% (50.0 ± 0.0 vs. 61.9 ± 4.6 mg; p < 0.001), shortened anesthesia duration (119.6 ± 18.3 vs. 131.8 ± 14.6 min; p = 0.002), and eliminated vascular injuries (0% vs. 16.2%; p = 0.025). All other outcomes demonstrated no statistically significant differences in the comparisons between the groups (p > 0.05).
Conclusions:
For children undergoing single-bar MIRPE, MINB provides noninferior analgesia to UINB with critical advantages: 65% faster placement, 19% lower ropivacaine dose, reduced anesthesia duration, and elimination of vascular injuries. These findings suggest that MINB offers a valuable alternative to UINB for post-MIRPE analgesia, as it appears to provide a more favorable balance between safety and efficiency.
Trail Registration:
Chinese Clinical Trial Registry: ChiCTR2200057961.
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