Status:
RECRUITING
The PAIN (Pelvic Area Injection for Numbness) Study
Lead Sponsor:
Montefiore Medical Center
Conditions:
Vaginal Laceration During Delivery
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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...
Detailed Description
Perineal lacerations, the disruption of the skin, mucosa and sometimes muscles that happen commonly during vaginal birth secondary to stretching of the introitus; are present in more than 75% of all v...
Eligibility Criteria
Inclusion
- \>= 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
- 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)
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05972681
Start Date
April 8 2025
End Date
July 1 2026
Last Update
June 4 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467