The PAIN (Pelvic Area Injection for Numbness) Study

Phase 4

Recruiting

• Conditions: Vaginal Laceration During Delivery
• Interventions: Other: Sham normal saline arm; Drug: Bupivacaine; Drug: Epinephrine

• Registration Number: NCT05972681
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Detailed Description

Perineal lacerations, the disruption of the skin, mucosa and sometimes muscles that happen commonly during vaginal birth secondary to stretching of the introitus; are present in more than 75% of all vaginal deliveries. These lacerations can be classified based on the location and depth (layers injured). However, the classification of these lacerations does not correlate necessarily with postpartum pain. Severe lacerations, as those compromising the external or internal anal sphincter are less common and associated with more postpartum pain.

It is common practice that only those lacerations causing bleeding, or distortion of normal pelvic anatomy are repaired. The repair of such lacerations at Montefiore Einstein is usually done using lidocaine for non-epiduralized patients; however, for patients with a functional epidural, no anesthetic agents are given locally to aid on long term pain control.

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.

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Study Start: 2025-04-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline sham arm	Sham normal saline arm	-
Local Anesthesia arm	Bupivacaine	Bupivicaine and Epinephrine
Local Anesthesia arm	Epinephrine	Bupivicaine and Epinephrine

Primary Outcome Measures

Name	Time	Method
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.
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
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)

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States