Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
NCT ID: NCT03470675
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2018-06-27
2024-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Epidural saline + IV saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
Epidural morphine 3 mg + IV saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
Interventions
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Epidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
Epidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Feyce M. Peralta, MD, MS
Principal Investigator
Principal Investigators
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Feyce Peralta, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
Chang SR, Chen KH, Lee CN, Shyu MK, Lin MI, Lin WA. Relationships between perineal pain and postpartum depressive symptoms: A prospective cohort study. Int J Nurs Stud. 2016 Jul;59:68-78. doi: 10.1016/j.ijnurstu.2016.02.012. Epub 2016 Feb 26.
Bauchat JR, Higgins N, Wojciechowski KG, McCarthy RJ, Toledo P, Wong CA. Low-dose ketamine with multimodal postcesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2011 Jan;20(1):3-9. doi: 10.1016/j.ijoa.2010.10.002.
Other Identifiers
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STU00206016
Identifier Type: -
Identifier Source: org_study_id
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