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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05417100
Other study ID # 22-015
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 6, 2022
Est. completion date June 2025

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact Jess Brallier, MD
Phone 212-639-6840
Email bralliej@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methadone
methadone 0.2 mg/kg IV.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary opioid requirement in morphine equivalent To see if giving methadone during surgery reduces the need for other pain medications after surgery within 72 hours post-surgery
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