A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Epidural administration of bolus (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization
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).
Clinical Details
Official title: A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in heat pain tolerance from baseline (using QST Medoc)
Secondary outcome: Change in electrical pain tolerance from baselinePlasma concentration of methadone, fentanyl, morphine (and metabolites) Pupilometry Respiratory rate and arterial CO2 tension
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: February 19, 2009
|