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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone bolus during surgery

Patients will be administered methadone 0.2 mg/kg (max 20 mg).

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

methadone 0.2 mg/kg IV.

No Methadone during surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methadone

methadone 0.2 mg/kg IV.

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No