- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848419
A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
September 10, 2019 updated by: Hadassah Medical Organization
The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the analgesic and side effect profiles of epidural methadone, fentanyl and morphine.
The investigators will compare the analgesic effect at three dermatomes to assess the rostral spread of drug, the investigators will assess plasma levels to assess the systemic redistribution of drug and the investigators will assess surrogate markers of central opiate effects (nasal capnography and pupilometry).
The investigators hypothesize that due to the long-duration of action of methadone, and its intermediate lipophilicity, that methadone will provide a predominantly segmental analgesia of long duration of action, with low rostral spread and low direct central depressant effects (including respiratory depression).
Study Overview
Study Type
Interventional
Phase
- Phase 3
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.
Exclusion Criteria:
- Inability to understand consent form; poor communication Refusal to sign consent form Contraindication to regional anesthesia Chronic opioid administration ASA classification 3 or greater Age < 18 or > 70
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Methadone
Epidural methadone bolus 4mg
|
|
Active Comparator: Morphine
Epidural morphine 4mg bolus
|
|
Active Comparator: Fentanyl
Epidural fentanyl 200 microgram bolus
|
|
Placebo Comparator: Saline
Epidural saline bolus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in heat pain tolerance from baseline (using QST Medoc)
Time Frame: At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
|
At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in electrical pain tolerance from baseline
Time Frame: At same time intervals as primary outcome
|
At same time intervals as primary outcome
|
Plasma concentration of methadone, fentanyl, morphine (and metabolites)
Time Frame: At each of the time intervals as for primary endpoint
|
At each of the time intervals as for primary endpoint
|
Pupilometry
Time Frame: At each of the time intervals as primary endpoint
|
At each of the time intervals as primary endpoint
|
Respiratory rate and arterial CO2 tension
Time Frame: At each of the time intervals as primary endpoint
|
At each of the time intervals as primary endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Exp pain 1-ginosar-HMO-CTIL
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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