Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Brief 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.

Intervention / Treatment

  • Drug: Epidural saline + IV saline
  • Drug: Epidural morphine 3 mg + IV saline
  • Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Condition or Disease

  • Pain
  • Postpartum Depression

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 160 ()
Funded by: Other

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Clinical Trial Dates

Start date: Jun 27, 2018
Primary Completion: Dec 31, 2021
Completion Date: Apr 30, 2022
Study First Posted: Mar 20, 2018
Results First Posted: Aug 31, 2020
Last Updated: Aug 05, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: Female
Minimum Age: 18

This clinical trial is recruiting

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More Details

NCT Number: NCT03470675
Other IDs: STU00206016
Study URL: https://ClinicalTrials.gov/show/NCT03470675
Last updated: Jan 27, 2021