Routine labour epidural analgesia versus labour analgesia on request: a randomised non‐inferiority trial

Abstract

Objective To assess the effect on mode of delivery of the routine use of labour epidural analgesia (EA) compared with analgesia on request.Design Randomised non-inferiority trial.Setting One university and one non-university teaching hospital in The Netherlands.Population Women with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks' gestation.Methods Participants were randomly allocated to receive either routine EA or analgesia on request. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed, with confidence intervals (CI) calculated for the differences in percentages or means.Main outcome measures Rate of operative delivery (instrumental vaginal or caesarean), labour characteristics, and adverse labour and neonatal outcomes.Results A total of 488 women were randomly allocated to the routine EA (n = 233) or analgesia on request group (n = 255).In the routine EA group, 89.3% (208/233) received EA. According to ITT analysis, 34.8% (81/233) women in the routine EA group had an operative delivery, compared with 26.7% (68/ 255) in the analgesia on request group (difference 8.1%, 95% CI À0.1 to 16.3). The difference in rate of operative deliveries according to the PP analysis was statistically significant (difference 8.9%, 95% CI 0.4 to 17.4). Inferiority of EA could not be rejected, as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10%. Women in the routine EA group had more adverse effects, including hypotension (difference 9.5%, 95% CI 4.2 to 14.9), and motor blockade (difference 6.8%, 95% CI 1.1 to 12.5).Conclusion Non-inferiority of routine EA could not be demonstrated in this trial. Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects. The results of our study do not justify routine use of EA.Keywords Caesarean section, epidural analgesia, instrumental vaginal delivery, labour analgesia analgesia, mode of delivery, operative delivery.Please cite this paper as: Wassen MMLH, Smits LJM, Scheepers HCJ, Marcus MAE, Van Neer J, Nijhuis JG, Roumen FJME. Routine labour epidural analgesia versus labour analgesia on request: a randomised non-inferiority trial. BJOG 2015;122:344-350.

Maternal quality of life in routine labor epidural analgesia versus labor analgesia on request: results of a randomized trial

“…This QOL study was linked to the recently published TREATtrial [24]. The trial was approved by the Medical Ethics Committee of the participating centres.…”

“…No important differences in labor and neonatal outcomes were found between both groups. However, routine EA use was likely to lead to more operative deliveries and more maternal adverse effects, including hypotension and motor blockade [24].…”

A year in review in Minerva Anestesiologica 2018

“…in the last year, Ma published other studies on postoperative analgesic regimens. Patientcontrolled epidural analgesia (Pcea) is largely used to control labor pain, but modalities are not standardized; 131,132 Matsota et al showed that the background infusion of local anesthetic and fentanyl decreased breakthrough pain, but did not affect maternal satisfaction and neonatal outcomes. 133 Manassero et al demonstrated that oral slow-release oxycodone was a valid alternative to Pcea with morphine in patients who underwent hip replacement under regional anesthesia.…”

Can oxytocin augmentation modify the risk of epidural analgesia by maternal age in cesarean sections?

“…In observational studies, the use of epidural analgesia has been associated with an increased risk of cesarean sections, but RCTs included in systematic reviews have refuted this association 166,170,173 . However, administering epidural analgesia as part of routine, compared to administration on request, has been found to increase the probability of a cesarean section 174 . The timing of the epidural, i.e., early or late in the first stage of labor, has not been found to influence the risk of cesarean section 175 .…”