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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Time to the third request for the pain medication

Safety Issue:

No

Principal Investigator

Natalia Moryl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-025

NCT ID:

NCT00142519

Start Date:

March 2005

Completion Date:

March 2012

Related Keywords:

  • Pain
  • Pain
  • Analgesics
  • Retroperitoneal lymph node dissection
  • Pain, Postoperative

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021