Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

January 2, 2019 updated by: Grace Shih, MD
The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.

One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
  • ASA status of I-III
  • BMI < 40
  • Able to understand and sign informed consent

Exclusion Criteria:

  • Severe pre-eclampsia
  • Conversion to general anesthetic
  • History of chronic opioid use
  • Allergy to morphine, or hydromorphone
  • Hyperemesis gravidarum
  • Emergency case
  • Patients who have an infection at the intended site of spinal insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydromorphone
100 mg, intrathecal administration
Drug: Hydromorphone
Injection of 100 mcg hydromorphone into the intrathecal space
Other Names:
  • DILAUDID® INJECTION
Active Comparator: Morphine
200 mg, intrathecal administration
Drug: Morphine
Injection of 200 mcg of intrathecal morphine
Other Names:
  • Duramorph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Scores
Time Frame: from Baseline to 24 Hours
Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable
from Baseline to 24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: up to 24 Hours
Patients will be monitored hourly for first 12 hours followed by every 2 hours for the next 12 hours. Masimo acoustic monitor will monitor respirations.
up to 24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace Shih, MD

Collaborators

Masimo Corporation

Investigators

  • Principal Investigator: Grace Shih, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 4, 2017

Study Completion (Actual)

October 22, 2018

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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