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Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

Primary Purpose

Spinal Surgery

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Methadone

Saline placebo

About this trial

This is an interventional treatment trial for Spinal Surgery focused on measuring Methadone, Pain Levels, Pain Medications, 22-015

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours
Postoperative hospital stay expected to be ≥ 2 nights at the time of consent

Exclusion Criteria:

Use of methadone currently or within the previous 6 weeks
Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin).
Current use of opioid antagonist/partial antagonist (i.e. buprenorphine).
Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium).
Patients with a BMI ≥ 36 kg/m2
2nd or 3rd degree heart block as assessed by preoperative EKG.
QTc > 450 msec on preoperative EKG.
Documentation of congestive heart failure and/or ejection fraction < 30% if recorded in the Pre-Operative Record.
Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids).
Any known hypersensitivity to methadone.
Pregnant or breastfeeding.
Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (> 75 U/L)
Serum Creatinine > 1.5 mg/dl
Instrumented spine cases of less than 2 levels
All non-instrumented spine cases
All intradural tumor resections
All "take backs" that occur within 72 hours of surgery (wound revisions, hematomas, etc.)

Sites / Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methadone bolus

Saline placebo

Arm Description

Patients will be administered methadone 0.2 mg/kg IV.

Patients will be administered 0.2 mg/kg IV of saline placebo.

Outcomes

Primary Outcome Measures

opioid requirement in morphine equivalent

To see if giving methadone during surgery reduces the need for other pain medications after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT05417100

First Posted

June 9, 2022

Last Updated

November 16, 2022

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05417100

Brief Title

Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

Official Title

Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Double-Blind, Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of methadone with the effects of a placebo to evaluate which one works best.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Surgery

Keywords

Methadone, Pain Levels, Pain Medications, 22-015

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Methadone bolus

Arm Type

Experimental

Arm Description

Patients will be administered methadone 0.2 mg/kg IV.

Arm Title

Saline placebo

Arm Type

Placebo Comparator

Arm Description

Patients will be administered 0.2 mg/kg IV of saline placebo.

Intervention Type

Drug

Intervention Name(s)

Methadone

Intervention Description

methadone 0.2 mg/kg IV.

Intervention Type

Other

Intervention Name(s)

Saline placebo

Intervention Description

Saline placebo

Primary Outcome Measure Information:

Title

opioid requirement in morphine equivalent

Description

To see if giving methadone during surgery reduces the need for other pain medications after surgery

Time Frame

within 72 hours post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours Postoperative hospital stay expected to be ≥ 2 nights at the time of consent Exclusion Criteria: Use of methadone currently or within the previous 6 weeks Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin). Current use of opioid antagonist/partial antagonist (i.e. buprenorphine). Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium). Patients with a BMI ≥ 36 kg/m2 2nd or 3rd degree heart block as assessed by preoperative EKG. QTc > 450 msec on preoperative EKG. Documentation of congestive heart failure and/or ejection fraction < 30% if recorded in the Pre-Operative Record. Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids). Any known hypersensitivity to methadone. Pregnant or breastfeeding. Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (> 75 U/L) Serum Creatinine > 1.5 mg/dl Instrumented spine cases of less than 2 levels All non-instrumented spine cases All intradural tumor resections All "take backs" that occur within 72 hours of surgery (wound revisions, hematomas, etc.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jess Brallier, MD

Phone

212-639-6840

bralliej@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick McCormick, MD

Phone

212-639-3862

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jess Brallier, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jess Brallier, MD

Phone

212-639-6840

First Name & Middle Initial & Last Name & Degree

Patrick McCormick, MD

Phone

212-639-3862

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

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