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

NCT00848419 | Withdrawn Phase 3

• 1 other identifier: Exp pain 1-ginosar-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Pain

Keywords

Epidural; Analgesia; Methadone; Morphine; Pharmacokinetic-pharmacodynamic; Experimental pain - analgesic response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in electrical pain tolerance from baseline

  At same time intervals as primary outcome

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

  At each of the time intervals as for primary endpoint

• Pupilometry

  At each of the time intervals as primary endpoint

• Respiratory rate and arterial CO2 tension

  At each of the time intervals as primary endpoint

Study Arms (4)

Methadone

ACTIVE COMPARATOR

Epidural methadone bolus 4mg

Drug: Epidural administration of bolus

Morphine

ACTIVE COMPARATOR

Epidural morphine 4mg bolus

Drug: Epidural administration of bolus

Fentanyl

ACTIVE COMPARATOR

Epidural fentanyl 200 microgram bolus

Drug: Epidural administration of bolus

Saline

PLACEBO COMPARATOR

Epidural saline bolus

Drug: Epidural administration of bolus

Interventions

Epidural administration of bolus DRUG

Fentanyl; Methadone; Morphine; Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2009-02