Epidural Methadone in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Epidurally administered opioid pain medications are important tools for postoperative pain control, but each agent has its own limitations. Methadone's properties suggest that it may provide a long duration of pain control with minimal side effects related to spread to the brain or absorption into the blood stream. In this study, the investigators aim to compare the relative pain relieving effects, markers of side effects, and concentrations in the blood of epidurally administered methadone as compared to another long-acting opioid which is commonly administered epidurally, morphine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: simon.haroutounian
• Treatments: Methadone; Morphine

Criteria

Inclusion Criteria:

1. Age ≥18;

2. Body mass index between 18.5 and 30

3. Good general health with no remarkable medical conditions;

4. Able and willing to provide informed consent.

Exclusion Criteria:

1. Known history of hepatic, renal, and cardiac disease;

2. Known history of diabetes mellitus;

3. Chronic pain;

4. A skin or spine condition preventing safe epidural catheter placement;

5. Current pregnancy or lactation;

6. Known coagulopathy or ongoing anticoagulant use which contraindicates epidural catheter placement;

7. Known allergic reactions to opioids or local anesthetics;

8. History of current or prior substance use disorder or positive screen using the 4-question Simple Screening Instrument for Substance Abuse (SSI-SA).