A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia

March 20, 2022 updated by: Hadassah Medical Organization

A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.

The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

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 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

* Elective laparotomy

Exclusion Criteria:

  • Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception
  • Illicit drug abusers
  • Chronic use of pain medication
  • Inability to understand consent form
  • Age < 18
  • Renal failure (Clcr<50 ml/min)
  • Chronic use of drugs that can alter plasma levels and\or effect of the study drugs
  • Corrected Q-T interval(QTc)=450msc and above
  • Contra-indication for epidural catheter insertion
  • Pregnancy

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: morphine, epidural
Epidurally administrated morphine
Drug: epidural morphine via PCEA
ACTIVE_COMPARATOR: fentanyl, epidural
epidurally administrated fentanyl
Drug: epidural fentanyl via PCEA
ACTIVE_COMPARATOR: methadone, epidural
epidurally administrated methadone
Drug: epidural methadone via PCEA
ACTIVE_COMPARATOR: morphine, intervenous
intravenously administrated morphine
Drug: intravenous morphine via PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
Time Frame: 72 hours post operatively
72 hours post operatively
Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline.
Time Frame: 72 hours post operatively
72 hours post operatively
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
Time Frame: 72 hours post operatively
72 hours post operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of opioid concentration in plasma as compared to baseline
Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Pupillometry as compared to baseline
Time Frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Respiratory rate as compared to baseline
Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Nasal capnography at rest as compared to baseline
Time Frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Report of adverse effects' severity as compared to baseline
Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Report of pain severity- at rest, cough and deep breathing as compared to baseline
Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

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

April 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 13, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0080-10-HMO

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.

Clinical Trials on Post Laparotomy Pain Treatment

Clinical Trials on epidural morphine via PCEA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe