The impact of intravenous infusion of tramadol and ondansetron vs. epidural analgesia on the quality of recovery after cesarean section: a prospective observational trial.

Abstract

Background: Optimizing post-cesarean recovery is crucial to facilitate neonatal care and improve maternal well-being. Post-cesarean neuraxial analgesia regimes are widely used, but can be resource intensive, not always feasible nor effective. Tramadol, with its dual mechanism of action and favorable safety profile, may offer an alternative. This study compared a tramadol-based continuous intravenous analgesia regimen with an epidural-based regimen with local anesthetics in terms of functional recovery and postoperative outcomes.

Methods: This prospective observational cohort study was carried out in women undergoing C-sections. Patients received either continuous intravenous infusion of tramadol and ondansetron (TRON) or patient-controlled epidural analgesia with ropivacaine (EPI). Patients were consecutively enrolled until the calculated sample size for each group was reached. The primary outcome was functional recovery at 24 hours, assessed using the Quality of Recovery-15 (QoR-15) scale. Secondary outcomes included recovery over 48 hours, obstetric-specific recovery (ObsQoR-10) at 24 hours, pain scores, adverse effects, and chronic pain at 90 days.

Results: A total of 312 patients were analyzed (156 per group). QoR-15 scores were higher in TRON compared to EPI (adjusted mean difference (AMD): 8.6 [95% CI: 4.7-12.0]; P<0.001 at 24 h and 12.0 [95% CI: 5.8-15.0]; P<0.001 at 48 h). ObsQoR-10 scores also favored TRON (AMD: 13 [95% CI: 10-16]; P<0.001). Pain control was slightly better in the TRON group and adverse effects were more frequent in the EPI group.

Conclusions: The TRON strategy offers an effective alternative for post-cesarean analgesia, with fewer side effects and easier postpartum care management. The addition of ondansetron likely played a key role.