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A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Epidural administration of bolus (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored 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).

Clinical Details

Official title: A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in heat pain tolerance from baseline (using QST Medoc)

Secondary outcome:

Change in electrical pain tolerance from baseline

Plasma concentration of methadone, fentanyl, morphine (and metabolites)


Respiratory rate and arterial CO2 tension


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: February 19, 2009

Page last updated: August 23, 2015

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