Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    160
  • sponsor
    Northwestern University
Updated on 28 January 2021
analgesia
morphine
ketamine
depressed mood
acute pain
epidural analgesia
vaginal delivery
pain relieving

Summary

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

Details
Condition Postpartum depression, Pain, Acute Pain Service, Post-Surgical Pain, Post-Partum Depression, Pain (Pediatric), ache
Treatment Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Clinical Study IdentifierNCT03470675
SponsorNorthwestern University
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18 years of age
English-speaking
Vaginal delivery (spontaneous or assisted)
A full-term fetus (>37 weeks' gestation)
OASIS as assessed by obstetrical provider
Functional epidural analgesia at time of delivery
Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion Criteria

Previous pelvic surgery
History of chronic pelvic pain
History of recurrent urinary tract infections
Women with known malformations of their urinary tract
True allergies to ketamine and/or morphine
Preeclampsia or hypertensive disorder at the time of delivery
Obstructive sleep apnea
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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