drugset / Trial / NCT03470675

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

NCT03470675 ↗

Phase 4 Completed 67 enrolled Northwestern University
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2018-06-27
Primary completion
2024-05-20
Completion
2024-06-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 0.3 mg/kg Intravenous
Comparator Morphine Other / unclassified 3 mg Other

Indications