Phase 4
Completed N=67
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Source: ClinicalTrials.gov NCT03470675 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries. — 3.5; 2.7; 2.4 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries. |
3.5; 2.7; 2.4 | — |
| SECONDARY Perineal Pain |
.1; .5; .3 | — |
| SECONDARY Assessment of Maternal-infant Bonding |
4.0; 3.6; 4.4 | — |
| SECONDARY Presence of Postpartum Depression |
5.1; 4.7; 4.8 | — |
| SECONDARY Brief Pain Inventory (BPI-ST Short Form) Current Pain |
.2; .6; 0.0 | — |
| SECONDARY Female Sexual Function |
13; 14.2; 14.8 | — |
| SECONDARY Promis 29 Profile (Physical Function Question Only) |
52.9; 54.8; 54.8 | — |
| SECONDARY Promis 29 Profile (Anxiety Function Question Only) |
44.8; 45.3; 46.7 | — |
| SECONDARY Promis 29 Profile (Depressive Symptoms Question Only) |
45; 43; 43.6 | — |
| SECONDARY Promis 29 Profile (Fatigue Question Only) |
45.9; 48.1; 50.0 | — |
| SECONDARY Promis 29 Profile (Sleep Disturbance Question Only) |
58.3; 56.0; 54.8 | — |
| SECONDARY Promis 29 Profile (Social Function Question Only) |
55.8; 53.8; 55.3 | — |
| SECONDARY Promis 29 Profile (Pain Interference Question Only) |
44; 43; 43.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03470675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.