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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Active, not recruiting

Phase 3

Conditions

Spinal Surgery

Treatments

Drug: Methadone

Study type

Interventional

Funder types

Other

Identifiers

NCT05417100

22-015

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.)