Expired Study
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New York, New York 10065


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00142519


Primary Contact:

Principal Investigator
Natalia Moryl, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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