Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Phase 4

Active, not recruiting

• Conditions: Postpartum Depression; Pain
• Interventions: Drug: Epidural morphine 3 mg + IV saline; Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg; Drug: Epidural saline + IV saline

• Registration Number: NCT03470675
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-20
• Study Start: 2018-06-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 67

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural morphine 3 mg + IV saline	Epidural morphine 3 mg + IV saline	3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg	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 saline + IV saline	Epidural saline + IV saline	Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.

Primary Outcome Measures

Name	Time	Method
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.	1 week after vaginal delivery	Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory (Short Form) Modified	3 months after delivery	7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief %. 0= no relief (poor) and 100% complete relief (good)
Promis 29 profile	3 month	29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good)
Assessment of maternal-infant bonding	3 months after delivery	Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
Maternal quality of life	3 months after delivery	Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
Perineal Pain	1 year after delivery	Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
Presence of postpartum depression	6 weeks after delivery	Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
Medoc Pathway Device Score	1 week post delivery	Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable
Female sexual function	3 months after delivery	Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States