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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2019-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Methadone

Epidural methadone bolus 4mg

Group Type ACTIVE_COMPARATOR

Epidural administration of bolus

Intervention Type DRUG

Morphine

Epidural morphine 4mg bolus

Group Type ACTIVE_COMPARATOR

Epidural administration of bolus

Intervention Type DRUG

Fentanyl

Epidural fentanyl 200 microgram bolus

Group Type ACTIVE_COMPARATOR

Epidural administration of bolus

Intervention Type DRUG

Saline

Epidural saline bolus

Group Type PLACEBO_COMPARATOR

Epidural administration of bolus

Intervention Type DRUG

Interventions

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Epidural administration of bolus

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No