Intercostal or Paravertebral Block vs Thoracic Epidural in Lung Surgery: A Randomized Noninferiority Trial.

Abstract

Importance Effective pain control after thoracic surgery is crucial for enhanced recovery. While thoracic epidural analgesia (TEA) traditionally ensures optimal analgesia, its adverse effects conflict with the principles of enhanced recovery after thoracic surgery. High-quality randomized data regarding less invasive alternative locoregional techniques are lacking. Objective To evaluate the efficacy of continuous paravertebral block (PVB) and a single-shot intercostal nerve block (ICNB) as alternatives to TEA. Design, Setting, and Participants This randomized clinical trial compared PVB and ICNB vs TEA (1:1:1) in patients undergoing thoracoscopic anatomical lung resection at 11 hospitals in the Netherlands and Belgium, enrolled from March 5, 2021, to September 5, 2023. The study used a noninferiority design for pain and a superiority design for quality of recovery (QoR). Interventions Continuous PVB and single-shot ICNB. Main Outcomes and Measures Primary outcomes were pain, defined as mean proportion of pain scores 4 or greater during postoperative days (POD) 0 through 2 (noninferiority margin for the upper limit [UL] 1-sided 98.65% CI, 17.5%), and QoR, assessed with the QoR-15 questionnaire at POD 1 and 2. Secondary measures included opioid consumption, mobilization, complications, and hospitalization. Results A total of 450 patients were randomized, with 389 included in the intention-to-treat (ITT) analysis (mean [SD] age, 66 [9] years; 208 female patients [54%] and 181 male [46%]). Of these 389 patients, 131 received TEA, 134 received PVB, and 124 received ICNB. The mean proportions of pain scores 4 or greater were 20.7% (95% CI, 16.5%-24.9%) for TEA, 35.5% (95% CI, 30.1%-40.8%) for PVB, and 29.5% (95% CI, 24.6%-34.4%) for ICNB. While PVB was inferior to TEA regarding pain (ITT: UL, 22.4%; analysis per-protocol [PP]: UL, 23.1%), ICNB was noninferior to TEA (ITT: UL, 16.1%; PP: UL, 17.0%). The mean (SD) QoR-15 scores were similar across groups: 104.96 (20.47) for TEA, 106.06 (17.94; P = .641) for PVB (P = .64 for that comparison), and 106.85 (21.11) for ICNB (P = .47 for that comparison). Both ICNB and PVB significantly reduced opioid consumption and enhanced mobility compared with TEA, with no significant differences in complications. Hospitalization was shorter in the ICNB group. Conclusions and Relevance After thoracoscopic anatomical lung resection, only ICNB provides noninferior pain relief compared with TEA. ICNB emerges as an alternative to TEA, although risks and benefits should be weighed for optimal personalized pain control. Trial Registration ClinicalTrials.gov Identifier: NCT05491239.