Trial intelligence / Profile preview

Multimodal Pain Management for Cesarean Delivery

NCT02922985Phase 4

Key facts

Status
Completed
Start
Oct 2016
Primary completion
Jun 2017
Countries
1
Sponsor
The University of Texas Medical Branch at Galveston
Modality
Small Molecules
Conditions
postoperative pain
01

Overview

Phase 4, randomised, double-blind trial of acetaminophen, bupivacaine hydrochloride 0.75% injection and ketorolac in postoperative pain (2 arms), sponsored by The University of Texas Medical Branch at Galveston. Primary endpoint: Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery. Started Oct 2016; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Multimodal Pain Regimen

    IV Acetaminophen + SC Bupivacaine + IM Ketorolac

  • Placebo Control

    Saline Placebo

03

Who it enrols

Women 18-45 years old undergoing elective cesarean delivery with spinal anesthesia.

04

Endpoints

Primary

  • Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery

Secondary

  • Time to First Administration of Opioid Pain Medication Post Operatively

  • Pain Score

  • Number of Opioid Pain Tablets Remaining on Post-operative Day #7

  • Hospital Length of Stay

  • Apgar Score at 5 Minutes

  • NICU Admission

  • Need for Respiratory Support

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