Intrathecal Hydromorphone for Pain Control After Cesarean Section

July 31, 2019 updated by: Yaakov Beilin, Icahn School of Medicine at Mount Sinai

Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.

Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.

Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.

In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

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
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

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:

  • Elective primary cesarean section
  • Females age 18-40

Exclusion Criteria:

  • Emergency cesarean section
  • Anesthetic other than spinal
  • History of chronic pain or pre-op opioid use
  • Allergy to morphine or hydromorphone
  • BMI>40

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intrathecal morphine
0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
Drug: Intrathecal morphine
0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
Other Names:
  • Duramorph
EXPERIMENTAL: Intrathecal hydromorphone
50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Drug: Intrathecal hydromorphone
50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Other Names:
  • Dilaudid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Fentanyl PCA Consumption
Time Frame: at 24 hours
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Initial PCA Use
Time Frame: up to 24 hours
When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.
up to 24 hours
Pain Score
Time Frame: at 24 hours
Assess pain scores on a scale of 1-5, with higher score indicating more pain.
at 24 hours
Patient Satisfaction Score
Time Frame: at 24 hours
Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction
at 24 hours
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus
Time Frame: up to 24 hours
Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.
up to 24 hours

Collaborators and Investigators

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

Sponsor

Icahn School of Medicine at Mount Sinai

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, 2014

Primary Completion (ACTUAL)

May 5, 2017

Study Completion (ACTUAL)

May 5, 2017

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 13-1762

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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