Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain.
Overview
- Phase
- Phase 2
- Intervention
- Methadone
- Conditions
- Pain
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The Primary Goal of This 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.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
methadone
Intervention: Methadone
2
methadone and morphine
Intervention: methadone and morphine
Outcomes
Primary Outcomes
The Primary Goal of This 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.
Time Frame: Time to the third request for the pain medication
Secondary Outcomes
- To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.(assessed every 10 minutes)