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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
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.
Details
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 100 |
| Start date | 2025-04-08 |
| Completion | 2026-07 |
Conditions
- Vaginal Laceration During Delivery
Interventions
- Bupivacaine
- Epinephrine
- Sham normal saline arm
Primary outcomes
- Time to first analgesic — Up to 24 hours after perineal laceration
Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable. - Maternal Satisfaction — 24 hours after perineal laceration
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) - Maternal Satisfaction — 48 hours after perineal laceration
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) - Maternal Satisfaction — 7 days after perineal laceration
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good) - Pain score after injection at perineal laceration — Immediately and 24 hours after perineal laceration
Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where "no pain" is on the left end (0 cm) of the scale and the "worst pain" is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions
Countries
United States