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Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study

NCT01943565 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-06-19

Study results available
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Summary

Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery.

For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.

Conditions

  • Healthy
  • Pain
  • Pregnancy

Interventions

DRUG

Hydromorphone 25mcg

Intrathecal Hydromorphone 25mcg

DRUG

Hydromorphone 50mcg

Intrathecal Hydromorphone 50mcg

DRUG

Hydromorphone 100mcg

Intrathecal Hydromorphone 100mcg

DRUG

spinal anesthesia

bupivacaine 0.75% 1.6 mL (12mg)

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Dirk J Varelmann, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01943565 on ClinicalTrials.gov