Hernia : the journal of hernias and abdominal wall surgery · 2025
Opioid-free versus opioid-based anesthesia for day surgery laparoscopic inguinal hernia repair under ERAS protocol: a randomized non-inferiority trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Wang Chun, Shi Peng, Xu Jun, Fan Xiaohua, Bian Jinjun, Bo Lulong
Аннотация
PURPOSE: Laparoscopic inguinal hernia repair (LIHR) is increasingly performed as a day surgery procedure under enhanced recovery after surgery (ERAS) protocol. While opioid-based anesthesia (OA) remains standard, its adverse effects may impair postoperative recovery. This randomized controlled non-inferiority trial assessed whether opioid-free anesthesia (OFA) provides non-inferior postoperative pain control to OA for day surgery LIHR under ERAS protocol and evaluated comprehensive recovery outcomes.
METHODS: This single-center, prospective, randomized non-inferiority trial enrolled 90 patients scheduled for day surgery LIHR who were randomly allocated to receive either lidocaine-dexmedetomidine-based OFA (n = 45) or sufentanil-remifentanil-based OA (n = 45). The primary outcome was postoperative 24-h time-weighted average visual analog scale (TWA-VAS) pain score at rest. Secondary outcomes included extended pain assessment, quality of recovery indicators, day surgery pathway efficiency, and perioperative hemodynamic stability.
RESULTS: The 24-h TWA-VAS scores were 1.84 ± 1.02 in the OFA group and 1.77 ± 0.88 in the OA group (mean difference: 0.07; 95% CI: -0.33-0.47), establishing non-inferiority. The OFA group experienced significantly lower rates of intraoperative hypotension (8.9% vs. 53.3%; relative risk: 0.17; P = 0.001) but longer laryngeal mask airway removal time (20 vs. 15 min; P = 0.034) and post-anesthesia care unit stay (50 vs. 45 min; P = 0.018). No significant differences were observed in Quality of Recovery-15 scores, rescue analgesia requirements, postoperative urinary retention (POUR), postoperative nausea and vomiting (PONV), or 24-h discharge success rates.
CONCLUSION: Under ERAS protocol, lidocaine-dexmedetomidine-based OFA provided non-inferior analgesic efficacy to OA for day surgery LIHR, while delivering superior hemodynamic stability. Despite modestly prolonged emergence times, OFA maintained comparable recovery quality and discharge success rates. These findings establish OFA as a valuable alternative anesthetic strategy for day surgery LIHR under ERAS protocol, particularly for patients at risk of opioid-related adverse effects.
TRIAL REGISTRATION: ChiCTR2500098054, registered on February 28, 2025, retrospectively registered.
METHODS: This single-center, prospective, randomized non-inferiority trial enrolled 90 patients scheduled for day surgery LIHR who were randomly allocated to receive either lidocaine-dexmedetomidine-based OFA (n = 45) or sufentanil-remifentanil-based OA (n = 45). The primary outcome was postoperative 24-h time-weighted average visual analog scale (TWA-VAS) pain score at rest. Secondary outcomes included extended pain assessment, quality of recovery indicators, day surgery pathway efficiency, and perioperative hemodynamic stability.
RESULTS: The 24-h TWA-VAS scores were 1.84 ± 1.02 in the OFA group and 1.77 ± 0.88 in the OA group (mean difference: 0.07; 95% CI: -0.33-0.47), establishing non-inferiority. The OFA group experienced significantly lower rates of intraoperative hypotension (8.9% vs. 53.3%; relative risk: 0.17; P = 0.001) but longer laryngeal mask airway removal time (20 vs. 15 min; P = 0.034) and post-anesthesia care unit stay (50 vs. 45 min; P = 0.018). No significant differences were observed in Quality of Recovery-15 scores, rescue analgesia requirements, postoperative urinary retention (POUR), postoperative nausea and vomiting (PONV), or 24-h discharge success rates.
CONCLUSION: Under ERAS protocol, lidocaine-dexmedetomidine-based OFA provided non-inferior analgesic efficacy to OA for day surgery LIHR, while delivering superior hemodynamic stability. Despite modestly prolonged emergence times, OFA maintained comparable recovery quality and discharge success rates. These findings establish OFA as a valuable alternative anesthetic strategy for day surgery LIHR under ERAS protocol, particularly for patients at risk of opioid-related adverse effects.
TRIAL REGISTRATION: ChiCTR2500098054, registered on February 28, 2025, retrospectively registered.