Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Epidural saline + IV saline
- Conditions
- Pain
- Sponsor
- Northwestern University
- Enrollment
- 67
- Locations
- 2
- Primary Endpoint
- Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
- Status
- Completed
- Last Updated
- 8 days ago
Overview
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.
Investigators
Feyce M. Peralta, MD, MS
Principal Investigator
Northwestern University
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
Arms & Interventions
Epidural saline + IV saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Intervention: Epidural saline + IV saline
Epidural morphine 3 mg + IV saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Intervention: Epidural morphine 3 mg + IV saline
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.
Intervention: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Outcomes
Primary Outcomes
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Time Frame: 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.
Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.
Time Frame: 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 (good)and 10 highest pain (poor).
Secondary Outcomes
- Brief Pain Inventory (Short Form) Modified(3 months after delivery)
- Promis 29 profile(3 month)
- Assessment of maternal-infant bonding(3 months after delivery)
- Maternal quality of life(3 months after delivery)
- Presence of postpartum depression(6 weeks after delivery)
- Medoc Pathway Device Score(1 week post delivery)
- Female sexual function(3 months after delivery)
- Perineal Pain(1 year after delivery)
- Perineal Pain(Day 1 after delivery)
- Perineal Pain(1 week after delivery)
- Assessment of Maternal-infant Bonding(1 week after delivery)
- Presence of Postpartum Depression(1 week after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(1 week after delivery)
- Presence of Postpartum Depression(6 weeks after delivery)
- Perineal Pain(6 weeks after delivery)
- Assessment of Maternal-infant Bonding(6 weeks after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(6 weeks after delivery)
- Perineal Pain(3 months after delivery)
- Assessment of Maternal-infant Bonding(3 months after delivery)
- Female Sexual Function(3 months after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(3 months after delivery)
- Promis 29 Profile (Physical Function Question Only)(3 month)
- Promis 29 Profile (Anxiety Function Question Only)(3 month)
- Promis 29 Profile (Depressive Symptoms Question Only)(3 month)
- Promis 29 Profile (Fatigue Question Only)(3 month)
- Promis 29 Profile (Sleep Disturbance Question Only)(3 month)
- Promis 29 Profile (Social Function Question Only)(3 month)
- Promis 29 Profile (Pain Interference Question Only)(3 month)