RECRUITING

The PAIN (Pelvic Area Injection for Numbness) Study

Description

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

Study Details

Study overview

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.

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

The PAIN (Pelvic Area Injection for Numbness) Study

Condition
Vaginal Laceration During Delivery
Intervention / Treatment

-

Contacts and Locations

Bronx

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

Fatima Estrada, MD, FACOG, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2026-07