Clinical trial NCT03470675: Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Official title: Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pain
Postpartum Depression
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
timeFrame: 1 week after vaginal delivery
Secondary outcomes:
measure: Perineal Pain
timeFrame: Day 1 after delivery
measure: Perineal Pain
timeFrame: 1 week after delivery
measure: Perineal Pain
timeFrame: 6 weeks after delivery
measure: Perineal Pain
timeFrame: 3 months after delivery
measure: Perineal Pain
timeFrame: 6 months after delivery
measure: Perineal Pain
timeFrame: 1 year after delivery
measure: Presence of postpartum depression
timeFrame: 1 week after delivery
measure: Presence of postpartum depression
timeFrame: 6 weeks after delivery
measure: Assessment of maternal-infant bonding
timeFrame: 1 week after delivery
measure: Assessment of maternal-infant bonding
timeFrame: 6 weeks after delivery
measure: Assessment of maternal-infant bonding
timeFrame: 3 months after delivery
measure: Medoc Pathway Device Score
timeFrame: 1 week post delivery
measure: Maternal quality of life
timeFrame: 3 months after delivery
measure: Female sexual function
timeFrame: 3 months after delivery
measure: Promis 29 profile
timeFrame: 6 week
measure: Promis 29 profile
timeFrame: 3 month
measure: Brief Pain Inventory (Short Form) Modified
timeFrame: 1 day after delivery
measure: Brief Pain Inventory (Short Form) Modified
timeFrame: 1 week after delivery
measure: Brief Pain Inventory (Short Form) Modified
timeFrame: 6 weeks after delivery
measure: Brief Pain Inventory (Short Form) Modified
timeFrame: 3 months after delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Feyce Peralta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
citation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
citation: Chang SR, Chen KH, Lee CN, Shyu MK, Lin MI, Lin WA. Relationships between perineal pain and postpartum depressive symptoms: A prospective cohort study. Int J Nurs Stud. 2016 Jul;59:68-78. doi: 10.1016/j.ijnurstu.2016.02.012. Epub 2016 Feb 26.
citation: Bauchat JR, Higgins N, Wojciechowski KG, McCarthy RJ, Toledo P, Wong CA. Low-dose ketamine with multimodal postcesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2011 Jan;20(1):3-9. doi: 10.1016/j.ijoa.2010.10.002.