A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00848419
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Epidural administration of bolus |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model |
Resource links provided by NLM:
Drug Information available for:
Morphine sulfate
Methadone
Fentanyl
Fentanyl citrate
Methadone hydrochloride
U.S. FDA Resources
Further study details as provided by Hadassah Medical Organization:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in electrical pain tolerance from baseline [ Time Frame: At same time intervals as primary outcome ] [ Designated as safety issue: No ]
- Plasma concentration of methadone, fentanyl, morphine (and metabolites) [ Time Frame: At each of the time intervals as for primary endpoint ] [ Designated as safety issue: No ]
- Pupilometry [ Time Frame: At each of the time intervals as primary endpoint ] [ Designated as safety issue: No ]
- Respiratory rate and arterial CO2 tension [ Time Frame: At each of the time intervals as primary endpoint ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Methadone
Epidural methadone bolus 4mg
|
Drug: Epidural administration of bolus |
|
Active Comparator: Morphine
Epidural morphine 4mg bolus
|
Drug: Epidural administration of bolus |
|
Active Comparator: Fentanyl
Epidural fentanyl 200 microgram bolus
|
Drug: Epidural administration of bolus |
|
Placebo Comparator: Saline
Epidural saline bolus
|
Drug: Epidural administration of bolus |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr Elyad Davidson, Director, Pain Unit, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00848419 History of Changes |
| Other Study ID Numbers: | Exp pain 1-ginosar-HMO-CTIL |
| Study First Received: | February 19, 2009 |
| Last Updated: | February 19, 2009 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Hadassah Medical Organization:
|
Epidural Analgesia Methadone |
Morphine Pharmacokinetic-pharmacodynamic Experimental pain - analgesic response |
Additional relevant MeSH terms:
|
Fentanyl Methadone Morphine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Antitussive Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013