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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848419

Enrollment

Registered

2009-02-20

Start date

2009-04-30

Completion date

2019-06-30

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Epidural, Analgesia, Methadone, Morphine, Pharmacokinetic-pharmacodynamic, Experimental pain - analgesic response

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).

Interventions

DRUGEpidural administration of bolus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026