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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• \>= 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Alyssa M Yeung, MD
ayeung@montefiore.org
574-329-8771
Backup
Fatima Estrada, MD, FACOG
festrada@montefiore.org
718-904-2767
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2026-07
Participants
Target number of participants: 100
Treatments
Experimental: Local Anesthesia arm
Bupivicaine and Epinephrine
Sham_comparator: Normal saline sham arm
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov