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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00848419
• Other study ID #: Exp pain 1-ginosar-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 2009
• Est. completion date: June 2019

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Epidural administration of bolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heat pain tolerance from baseline (using QST Medoc)		At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
Secondary	Change in electrical pain tolerance from baseline		At same time intervals as primary outcome
Secondary	Plasma concentration of methadone, fentanyl, morphine (and metabolites)		At each of the time intervals as for primary endpoint
Secondary	Pupilometry		At each of the time intervals as primary endpoint
Secondary	Respiratory rate and arterial CO2 tension		At each of the time intervals as primary endpoint