The PAIN (Pelvic Area Injection for Numbness) Study
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Vaginal Laceration During Delivery
In brief
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.
Key facts
- Study ID
- NCT05972681
- Run by
- Montefiore Medical Center
- People needed
- 3
- Starts
- 2025-04-08
- Expected to finish
- 2025-10-19
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy with a singleton pregnancy
- English or Spanish speaking
- Ongoing functioning epidural throughout the laceration repair
- Multiparous or nulliparous
- Ability to consent for themselves
You may not qualify if…
- Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
- Have multiple gestations
- Complaints of non-functioning epidural
- Allergic to bupivacaine and/or epinephrine
- 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)
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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