Comparison of enhanced recovery after surgery protocol and standard protocol for cesarean delivery: A two-center, double-blind, randomized controlled trial.

BACKGROUND: Enhanced recovery after cesarean delivery (ERAC) protocols have been designed to optimize maternal recovery. Although its potential has been demonstrated, high-quality evidence supporting the efficacy of ERAC protocols remains limited. This study aimed to evaluate the effect of anesthesiologist-led bundled ERAC interventions on perioperative adverse events and recovery quality. METHODS: In this two-center, double-blind, randomized controlled trial, 122 women undergoing elective cesarean delivery under spinal anesthesia were allocated to receive either conventional care or a bundled ERAC protocol. The ERAC bundle included: preoperative personalized and information-based education; intraoperative prophylactic phenylephrine infusion, mandatory non-opioid analgesia (intravenous acetaminophen and ketorolac), prophylaxis for postoperative nausea and vomiting (ondansetron/dexamethasone), and active fluid warming; and postoperative scheduled ketorolac. The primary outcome was a composite of perioperative adverse events (hypotension, nausea/vomiting, shivering, pruritus, hypothermia, and moderate-to-severe pain). Secondary outcomes included opioid consumption, length of hospital stay, pain scores at rest and with movement, the ObsQoR-11 recovery score, and anxiety scores. RESULTS: Among 116 participants who completed the study (57 conventional care, 59 ERAC), the incidence of the primary composite outcome was significantly lower in the ERAC group (45% vs. 71%; absolute risk difference -31.4%, 95% CI -48.1% to -14.7%; odds ratio 0.25, 95% CI 0.11 to 0.56; P = 0.001). On postoperative day 1, the ERAC group demonstrated superior recovery, with lower worst pain scores (P<0.01), lower pain scores with movement (P<0.01), fewer patient-controlled analgesia boluses (P<0.01), and higher ObsQoR-11 scores (P<0.01). No significant differences were found in pain at rest, length of stay, or anxiety scores. CONCLUSION: An anesthesiologist-led, bundled ERAC protocol significantly reduced perioperative adverse events and enhanced the quality of recovery after elective cesarean delivery compared to conventional care.