A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
- Conditions
- Pain
- Interventions
- Drug: Epidural administration of bolus
- Registration Number
- NCT00848419
- Lead Sponsor
- Hadassah Medical Organization
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methadone Epidural administration of bolus Epidural methadone bolus 4mg Morphine Epidural administration of bolus Epidural morphine 4mg bolus Saline Epidural administration of bolus Epidural saline bolus Fentanyl Epidural administration of bolus Epidural fentanyl 200 microgram bolus
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pupilometry At each of the time intervals as primary endpoint Plasma concentration of methadone, fentanyl, morphine (and metabolites) At each of the time intervals as for primary endpoint Change in electrical pain tolerance from baseline At same time intervals as primary outcome Respiratory rate and arterial CO2 tension At each of the time intervals as primary endpoint