RecruitingPhase 4NCT05972681

The PAIN (Pelvic Area Injection for Numbness) Study

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


Sponsor

Montefiore Medical Center

Enrollment

100 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • >= 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 Criteria8

  • 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)

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Interventions

DRUGBupivacaine

10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.

DRUGEpinephrine

Epinephrine (1:200,000) injected to the vaginal laceration site.

OTHERSham normal saline arm

10 milliliter (ml) of normal saline injected to the vaginal laceration site.


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05972681