Clinical trial

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial

Name
STU00206016
Description
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.
Trial arms
Trial start
2018-06-27
Estimated PCD
2024-05-30
Trial end
2024-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Epidural saline + IV saline
Sterile saline injection in the epidural catheter and in the intravenous catheter
Arms:
Epidural saline + IV saline
Epidural morphine 3 mg + IV saline
Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
Arms:
Epidural morphine 3 mg + IV saline
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
Arms:
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Size
67
Primary endpoint
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
1 week after vaginal delivery
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}
Updated at
2023-10-27

1 organization

3 products

2 indications

Product
Saline
Indication
Pain