A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
Overview
- Phase
- Phase 3
- Intervention
- Epidural administration of bolus
- Conditions
- Pain
- Sponsor
- Hadassah Medical Organization
- Primary Endpoint
- Change in heat pain tolerance from baseline (using QST Medoc)
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Methadone
Epidural methadone bolus 4mg
Intervention: Epidural administration of bolus
Morphine
Epidural morphine 4mg bolus
Intervention: Epidural administration of bolus
Fentanyl
Epidural fentanyl 200 microgram bolus
Intervention: Epidural administration of bolus
Saline
Epidural saline bolus
Intervention: Epidural administration of bolus
Outcomes
Primary Outcomes
Change in heat pain tolerance from baseline (using QST Medoc)
Time Frame: At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
Secondary Outcomes
- 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)