Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

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


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.

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


Yes No Not Sure

Inclusion Criteria

Age >18 years of age
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note