The PAIN (Pelvic Area Injection for Numbness) Study (PAIN)

May 26, 2026 updated by: Montefiore Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Normal saline sham arm
Other: Sham normal saline arm
10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Experimental: Local Anesthesia arm
Bupivicaine and Epinephrine
Drug: Bupivacaine
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
Drug: Epinephrine
Epinephrine (1:200,000) injected to the vaginal laceration site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Analgesic
Time Frame: Up to 24 hours after perineal laceration
The average time to first analgesic (TFA), in minutes, will be evaluated as the duration interval from injection to administration of the first analgesic, as applicable.
Up to 24 hours after perineal laceration
Maternal Satisfaction
Time Frame: 24 hours, 48 hours, and 7 days after perineal laceration
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities. Participants will rate their ability to carry out these activities at 24 hours, 48 hours and 7 days using a 5-point scale (1 = very good; 2 = good; 3 = neutral; 4 = poor; or 5 = very poor) such that lower scores are indicative of increased ability to execute daily living activities. No descriptive statistics were completed given the small sample size.
24 hours, 48 hours, and 7 days after perineal laceration
Pain Score After Injection at Perineal Laceration
Time Frame: 24 hours, 48 hours, and 7 days 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. No descriptive statistics were completed given the small sample size.
24 hours, 48 hours, and 7 days after perineal laceration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Fatima Estrada, MD, FACOG, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Actual)

October 19, 2025

Study Completion (Actual)

October 19, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-14825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginal Laceration During Delivery

Clinical Trials on Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe