Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

October 20, 2022 updated by: Dr. Evan Goodman, MD, Goodman, Evan, M.D.

A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia

For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI > 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.

All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case 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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients having an elective Cesarean section
  • Healthy women (ASA I or II)
  • Regional anesthesia candidates

Exclusion Criteria:

  • Morbid obesity (BMI>40)
  • Sleep apnea
  • Age under 18
  • Intolerance or addiction to opioids

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Preservative free morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Drug: Preservative free morphine
3mg given epidurally during the Cesarean section.
Other Names:
  • Duramorph
ACTIVE_COMPARATOR: Fentanyl infusion
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Drug: Fentanyl
An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
Other Names:
  • PCA fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postsurgical Pain
Time Frame: At 8, 24 36 and 48 hours after the Cesarean section
Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.
At 8, 24 36 and 48 hours after the Cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Responded Yes to Having Nausea or Vomiting
Time Frame: At 8, 24, 36 and 48 hours after the Cesarean section
The patient will be asked whether she has nausea or vomiting (yes=1, no=0).
At 8, 24, 36 and 48 hours after the Cesarean section
Patient Satisfaction
Time Frame: At 8, 24, 48 and 36 hours after Cesarean section
Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).
At 8, 24, 48 and 36 hours after Cesarean section
Number of Participants Who Responded Yes to Having Back Pain
Time Frame: At 8, 24, 36 and 48 hours after the Cesarean section
Participants will be asked whether they have back pain (Yes=1, No=0)
At 8, 24, 36 and 48 hours after the Cesarean section
Number of Participants Who Responded Yes to Having Pruritis
Time Frame: At 8, 24, 36 and 48 hours after Cesarean section
Participants will be asked whether they have pruritis (Yes=1, No=0)
At 8, 24, 36 and 48 hours after Cesarean section
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
Time Frame: At 8, 24, 36 and 48 hours after Cesarean section
Participant's nurse will be asked whether >400ml was obtained by straight cath (Y=1, No=0)
At 8, 24, 36 and 48 hours after Cesarean section
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
Time Frame: At 8, 24, 36 and 48 hours after the Cesarean section
Participant's chart will be examined to determine whether the respiratory rate was <8 per minute (Yes=1, No=0)
At 8, 24, 36 and 48 hours after the Cesarean section

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Required Additional Pain Medications
Time Frame: At 8, 24, 36 and 48 hours after the Cesarean section
Participant's nurse will be asked whether the patient required additional pain medications (Yes=1, No=0)
At 8, 24, 36 and 48 hours after the Cesarean section

Collaborators and Investigators

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

Sponsor

Goodman, Evan, M.D.

Investigators

  • Principal Investigator: Evan Goodman, MD, University Hospitals Cleveland Medical Center

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 (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (ESTIMATE)

June 1, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • goodman-2

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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