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Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose

NCT02009722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-07-25

Study results available
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Summary

Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.

Conditions

  • Analgesia, Obstetrical
  • Cesarean Section

Interventions

DRUG

Morphine

Duramorph is administered as part of spinal anesthesia for post-operative pain relief.

DRUG

Hydromorphone

Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control

Sponsors & Collaborators

Principal Investigators

  • Hans P Sviggum, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02009722 on ClinicalTrials.gov