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

Hadassah Medical Center

Status and phase: Withdrawn; Phase 3

Conditions: Pain

Treatments: Drug: Epidural administration of bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT00848419

Exp pain 1-ginosar-HMO-CTIL

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Methadone

Active Comparator group

Description:

Epidural methadone bolus 4mg

Treatment:

Drug: Epidural administration of bolus

Morphine

Active Comparator group

Description:

Epidural morphine 4mg bolus

Treatment:

Drug: Epidural administration of bolus

Fentanyl

Active Comparator group

Description:

Epidural fentanyl 200 microgram bolus

Treatment:

Drug: Epidural administration of bolus

Saline

Placebo Comparator group

Description:

Epidural saline bolus

Treatment:

Drug: Epidural administration of bolus