The PAIN (Pelvic Area Injection for Numbness) Study
Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair
of such lacerations in the institution is usually done using lidocaine for non-epiduralized
patients versus no local injection in patients with a pre-existing epidural analgesia. The
prevalence of epidural analgesia use among women who underwent vaginal delivery in
cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the
analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled
postpartum pain which can affect both the physical and mental recovery period, extend
hospital stays, and increase the potential for serious adverse reactions with pain
medications.
The research hypothesis of this study is that adding a locally injected analgesic, which will
take effect once the epidural analgesia fades, may alleviate perineal pain and improve
women's overall well-being and satisfaction.
This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial
with the objective to determine if prolonged analgesia and higher rate of maternal
satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal
repair as compared to sham injection in patients with pre-existing effective epidural
analgesia at time of perineal laceration repair. Women with a working epidural analgesia, and
status post a vaginal delivery involving a second-degree laceration will be invited to
participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration
and women in the sham arm will get an injection with saline. The differences in perineal pain
between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal
satisfaction at 24 hours, and visual analog scale (VAS) pain score.