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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05417100
Collaborator
(none)
210
Enrollment
1
Location
2
Arms
35.8
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methadone bolus

Patients will be administered methadone 0.2 mg/kg IV.

Drug: Methadone
methadone 0.2 mg/kg IV.
Placebo Comparator: Saline placebo

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

Other: Saline placebo
Saline placebo

Outcome Measures

Primary Outcome Measures

  1. opioid requirement in morphine equivalent [within 72 hours post-surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Current use of a sustained-release or long-acting opioid

  • 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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jess Brallier, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT05417100
Other Study ID Numbers:
  • 22-015
First Posted:
Jun 14, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Methadone
Pain Levels
Pain Medications
22-015
Additional relevant MeSH terms:
Methadone

Study Results

No Results Posted as of Aug 19, 2022