Two Dose Epidural Morphine for Post-cesarean Analgesia

November 19, 2015 updated by: Allison Lee, Columbia University
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

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, 10032
        • New York Presbyterian Hospital

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria:

  • Emergent cesarean section
  • Coagulopathy
  • Failed epidural anesthesia or patchy block
  • General anesthesia
  • Use of epidural chloroprocaine
  • Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
  • Severe opioid side effects
  • History of chronic opioid use
  • History of chronic pain
  • History of obstructive sleep apnea
  • Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
  • Height under 4' 10" (147 cm)
  • Documented dural puncture by the epidural (Tuohy) needle
  • Preeclampsia
  • Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epidural Morphine
Group receiving 3mg epidural morphine, 24 hours after the initial dose
Drug: Epidural Morphine
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
Other Names:
  • DepoDur
Placebo Comparator: Epidural Saline
Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Drug: Epidural Saline
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Other Names:
  • Sodium Chloride Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
Time Frame: Up to 48 hours post-operatively
The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
Up to 48 hours post-operatively

Collaborators and Investigators

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

Sponsor

Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAL3857

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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