Actively Recruiting
The PAIN (Pelvic Area Injection for Numbness) Study
Led by Montefiore Medical Center · Updated on 2025-06-04
100
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The PAIN (Pelvic Area Injection for Numbness) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Healthy with a singleton pregnancy
- English or Spanish speaking
- Functioning epidural throughout the laceration repair
- Multiparous or nulliparous
- Ability to consent for themselves
You will not qualify if you...
- Operative vaginal delivery with postpartum hemorrhage
- Vaginal delivery complicated by postpartum hemorrhage
- Multiple gestations
- Non-functional epidural
- Allergy to bupivacaine or epinephrine
- Combined spinal-epidural (CSE) epidural
- Epidural top-off within 3 hours before perineal repair
- Severe pain (score above 3 on 0-10 scale) at time of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
A
Alyssa M Yeung, MD
CONTACT
F
Fatima Estrada, MD, FACOG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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