Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain

NCT ID: NCT00142519

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2018-07-31

Brief Summary

This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain. A second goal is to further evaluate any side effects of the combination of morphine and methadone.

Detailed Description

Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice.

Purpose:

This is a randomized, double blind, parallel arm Phase II study comparing a single dose of 1:1 combination of methadone and morphine with morphine alone in patients with post-operative pain.

• The primary objective of this randomized, double blind, parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain.
• A second goal is to further evaluate any side effects of the combination of morphine and methadone.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

methadone

Group Type: ACTIVE_COMPARATOR

Methadone

Intervention Type: DRUG

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg

2

methadone and morphine

Group Type: EXPERIMENTAL

methadone and morphine

Intervention Type: DRUG

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

Interventions

Methadone

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg

Intervention Type: DRUG

methadone and morphine

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Retroperitoneal lymph node dissection
• Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
• 18 years of age or older
• English-speaking
• Give informed consent to participate in this study

Exclusion Criteria

• Known hypersensitivity to methadone or morphine
• Patients with past or present history of substance abuse
• Patients with a history of methadone treatment
• Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
• Patients treated with opioids within one month from the scheduled surgery
• Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
• Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Moryl, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

05-025

Identifier Type: -

Identifier Source: org_study_id