Ropivacaine perineal infiltration for postpartum pain management in episiotomy repair: a double-blind, randomised, placebo-controlled trial.

OBJECTIVE

To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo.

DESIGN

Two-centre, double-blind, randomised, controlled trial.

SETTING

Two French maternity units, October 2017 to April 2020.

POPULATION

272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair.

METHODS

Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months).

MAIN OUTCOME MEASURES

The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI).

RESULTS

Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life.

CONCLUSIONS

This study did not demonstrate any benefit of ropivacaine infiltration over placebo.