Phase
Condition
Spinal Surgery
Treatment
Saline placebo
Methadone
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients (between 18-75 years of age) scheduled for extradural spine surgerywith instrumentation (greater than or equal to two levels and including minimallyinvasive) of expected duration ≥ 2 hours
Postoperative hospital stay expected to be ≥ 2 nights at the time of consent
Exclusion
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 recordedin 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 IVacetaminophen: 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
Connect with a study center
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.