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The PAIN (Pelvic Area Injection for Numbness) Study
Sponsor: Montefiore Medical Center
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.
Official title: A Randomized Controlled Trial of Bupivacaine With Epinephrine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia: The PAIN Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-04-08
Completion Date
2026-07
Last Updated
2025-06-04
Healthy Volunteers
Yes
Conditions
Interventions
Bupivacaine
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
Epinephrine
Epinephrine (1:200,000) injected to the vaginal laceration site.
Sham normal saline arm
10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Locations (1)
Montefiore Medical Center
The Bronx, New York, United States