Injecting pain relief for vaginal lacerations after delivery
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
This study is testing if a pain relief injection can help women with vaginal tears after childbirth feel better once their epidural wears off.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05972681 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a locally injected analgesic, bupivacaine, combined with epinephrine, for women who experience vaginal lacerations during delivery and have received epidural analgesia. The goal is to alleviate postpartum perineal pain once the effects of the epidural fade, potentially improving recovery and overall satisfaction. The study employs a superiority design with two arms, including a sham saline group, and is quadruple-blinded to ensure unbiased results. Participants will be monitored for pain relief and overall well-being following the intervention.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18 and older with a singleton pregnancy who are receiving epidural analgesia during vaginal delivery.
Not a fit: Patients who have experienced complications such as postpartum hemorrhage or those with non-functional epidurals may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postpartum pain and enhance recovery for women after vaginal delivery.
How similar studies have performed: While similar approaches have been explored, this specific method of using a local injection post-epidural for vaginal lacerations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>= 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 Criteria: * 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)
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Fatima Estrada, MD, FACOG — Montefiore Medical Center
- Study coordinator: Alyssa M Yeung, MD
- Email: ayeung@montefiore.org
- Phone: 574-329-8771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.