RECRUITING

The PAIN (Pelvic Area Injection for Numbness) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-08
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05972681

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>= 18 years old
  2. * Healthy with a singleton pregnancy
  3. * English or Spanish speaking
  4. * Ongoing functioning epidural throughout the laceration repair
  5. * Multiparous or nulliparous
  6. * Ability to consent for themselves
  1. * Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
  2. * Vaginal delivery was complicated by a postpartum hemorrhage
  3. * Have multiple gestations
  4. * Complaints of non-functional epidural
  5. * Allergic to bupivacaine and/or epinephrine
  6. * Epidural was a combined spinal-epidural (CSE)
  7. * Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) \< 3 hours from the perineal repair
  8. * Experienced extreme pain at time of study consent (pain scale score \> 3 on 0-10 scale)

Contacts and Locations

Study Contact

Alyssa M Yeung, MD
CONTACT
574-329-8771
ayeung@montefiore.org
Fatima Estrada, MD, FACOG
CONTACT
718-904-2767
festrada@montefiore.org

Principal Investigator

Fatima Estrada, MD, FACOG
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

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

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 Registration Dates

Study Start Date2025-04-08
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-04-08
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Vaginal Laceration During Delivery