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Recruiting Phase 4 NCT05972681

The PAIN (Pelvic Area Injection for Numbness) Study

Trial Parameters

Condition Vaginal Laceration During Delivery
Sponsor Montefiore Medical Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-04-08
Completion 2026-07
Interventions
BupivacaineEpinephrineSham normal saline arm

Brief Summary

Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. 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. The objective of this study is 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.

Eligibility Criteria

Inclusion Criteria: * \>= 18 years old * Healthy with a singleton pregnancy * English or Spanish speaking * Ongoing functioning epidural throughout the laceration repair * Multiparous or nulliparous * Ability to consent for themselves Exclusion Criteria: * Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage * Vaginal delivery was complicated by a postpartum hemorrhage * Have multiple gestations * Complaints of non-functional epidural * Allergic to bupivacaine and/or epinephrine * Epidural was a combined spinal-epidural (CSE) * Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) \< 3 hours from the perineal repair * Experienced extreme pain at time of study consent (pain scale score \> 3 on 0-10 scale)

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