The PAIN (Pelvic Area Injection for Numbness) Study
Purpose
The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications. 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. This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial with the objective 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. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.
Condition
- Vaginal Laceration During Delivery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- >= 18 years old - Healthy with a singleton pregnancy - English or Spanish speaking - Ongoing functioning epidural throughout the laceration repair - Ability to consent for themselves
Exclusion Criteria
- Women who underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage - Multiple gestation - 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)
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Randomization will be blinded to the patient, the nurse carrying for the patient and providing the randomized, unlabeled syringe, the provider performing the perineal repair, the research team asking the maternal satisfaction questions, and the researcher analyzing the data. To assure blinding, the selection of the medication given, and the preparation of such medication will be performed by the labor and delivery anesthesia team. No one involved directly in the perineal laceration repair, or obtaining research information, nor the patient, will know what was injected.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Local Anesthesia arm |
Bupivicaine and Epinephrine |
|
|
Sham Comparator Normal saline sham arm |
|
Recruiting Locations
Bronx, New York 10467
More Details
- NCT ID
- NCT05972681
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center