Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Cluster Randomization Trial
Overview
- Phase
- Phase 3
- Intervention
- Methadone
- Conditions
- Spinal Surgery
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- opioid requirement in morphine equivalent
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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 the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.
Investigators
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.
Arms & Interventions
Methadone bolus during surgery
Patients will be administered methadone 0.2 mg/kg (max 20 mg).
Intervention: Methadone
No Methadone during surgery
No Methadone during surgery
Outcomes
Primary Outcomes
opioid requirement in morphine equivalent
Time Frame: within 72 hours post-surgery
To see if giving methadone during surgery reduces the need for other pain medications after surgery