Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

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

Sponsors

Lead Sponsor: Northwestern University

Source Northwestern University
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.

Overall Status Recruiting
Start Date 2018-06-27
Completion Date 2023-04-30
Primary Completion Date 2022-12-31
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries. 1 week after vaginal delivery
Secondary Outcome
Measure Time Frame
Perineal Pain Day 1 after delivery
Perineal Pain 1 week after delivery
Perineal Pain 6 weeks after delivery
Perineal Pain 3 months after delivery
Perineal Pain 6 months after delivery
Perineal Pain 1 year after delivery
Presence of postpartum depression 1 week after delivery
Presence of postpartum depression 6 weeks after delivery
Assessment of maternal-infant bonding 1 week after delivery
Assessment of maternal-infant bonding 6 weeks after delivery
Assessment of maternal-infant bonding 3 months after delivery
Medoc Pathway Device Score 1 week post delivery
Maternal quality of life 3 months after delivery
Female sexual function 3 months after delivery
Promis 29 profile 6 week
Promis 29 profile 3 month
Brief Pain Inventory (Short Form) Modified 1 day after delivery
Brief Pain Inventory (Short Form) Modified 1 week after delivery
Brief Pain Inventory (Short Form) Modified 6 weeks after delivery
Brief Pain Inventory (Short Form) Modified 3 months after delivery
Enrollment 160
Condition
Intervention

Intervention Type: Drug

Intervention Name: Epidural saline + IV saline

Description: Sterile saline injection in the epidural catheter and in the intravenous catheter

Arm Group Label: Epidural saline + IV saline

Intervention Type: Drug

Intervention Name: Epidural morphine 3 mg + IV saline

Description: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter

Arm Group Label: Epidural morphine 3 mg + IV saline

Intervention Type: Drug

Intervention Name: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Description: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

Arm Group Label: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Feyce Peralta, MD Principal Investigator Northwestern University
Overall Contact

Last Name: Feyce M Peralta, MD

Phone: 312-472-3585

Email: [email protected]

Location
Facility: Status: Contact: Northwestern University Feyce M Peralta, MD 312-472-3585 [email protected]
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Northwestern University

Investigator Full Name: Feyce M. Peralta

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Epidural saline + IV saline

Type: Placebo Comparator

Description: Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.

Label: Epidural morphine 3 mg + IV saline

Type: Active Comparator

Description: 3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.

Label: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Type: Active Comparator

Description: 3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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