NCT03470675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jun 2018

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

March 2, 2018

Results QC Date

March 13, 2026

Last Update Submit

April 7, 2026

Conditions

PainPostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.

    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).

    1 week after vaginal delivery

Secondary Outcomes (21)

  • 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

  • +16 more secondary outcomes

Study Arms (3)

Epidural saline + IV saline

PLACEBO COMPARATOR

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

Drug: Epidural saline + IV saline

Epidural morphine 3 mg + IV saline

ACTIVE COMPARATOR

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

Drug: Epidural morphine 3 mg + IV saline

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

ACTIVE COMPARATOR

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

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

Interventions

Epidural morphine 3 mg + IV salineDRUG

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

Epidural morphine 3 mg + IV saline
Epidural morphine 3 mg + IV ketamine 0.3 mg/kgDRUG

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

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Epidural saline + IV salineDRUG

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

Epidural saline + IV saline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • 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.

    PMID: 26637088BACKGROUND

  • 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.

    PMID: 15507941BACKGROUND

  • 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.

    PMID: 27222452BACKGROUND

  • 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.

    PMID: 21224020BACKGROUND

MeSH Terms

Conditions

PainDepression, Postpartum

Interventions

Sodium ChlorideKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

This project enrollment was closed early because of loss of funding.

Results Point of Contact

Title
Paul C. Fitzgerald, RN, BSN, MS
Organization
Northwestern University
p-fitzgerald2@northwestern.edu
312-695-1064

Study Officials

  • Feyce Peralta, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 20, 2018

Study Start

June 27, 2018

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

April 24, 2026

Results First Posted

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)