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
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Drug: Epidural saline + IV saline
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Drug: Epidural morphine 3 mg + IV saline
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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 | |
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| 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
Location
Eligibility Criteria
| Sex: | Female |
|---|---|
| Minimum Age: | 18 |
This clinical trial is recruiting
Are you interested in participating in this trial or others? We'd love to help.
More Details
| NCT Number: | NCT03470675 |
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| Other IDs: | STU00206016 |
| Study URL: | https://ClinicalTrials.gov/show/NCT03470675 |