Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Postpartum Depression; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03470675

STU00206016

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 3 patient groups, including a placebo group

Epidural saline + IV saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Epidural saline + IV saline

Epidural morphine 3 mg + IV saline

Active Comparator group

Description:

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

Treatment:

Drug: Epidural morphine 3 mg + IV saline

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Active Comparator group

Description:

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

Treatment:

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