The PAIN (Pelvic Area Injection for Numbness) Study (NCT05972681) | Clinical Trial Compass
TerminatedPhase 4
The PAIN (Pelvic Area Injection for Numbness) Study
Stopped: Difficulty with enrollment
United States3 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Analgesic
Timeframe: Up to 24 hours after perineal laceration
2
Maternal Satisfaction
Timeframe: 24 hours, 48 hours, and 7 days after perineal laceration
3
Pain Score After Injection at Perineal Laceration
Timeframe: 24 hours, 48 hours, and 7 days after perineal laceration