Methadone for Post-operative Spine Surgery

Phase 4Not Yet RecruitingNCT07517679

Brandon Knopp30 enrolled

Overview

The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups. Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay. Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group. Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg) If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing elective spine surgery (e.g., fusion, decompression) * Expected postoperative inpatient admission * Able to provide informed consent * Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy Exclusion Criteria: * Use of regional or neuraxial anesthesia * Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease) * Cognitive impairment precluding consent or accurate pain scoring

Outcomes

Primary Outcomes

Perioperative Opioid use in morphine equivalents (ME)

perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)

Time frame: Perioperative until 72 hours postoperative

Secondary Outcomes

Change in numeric rating scale (NRS) pain scores

Pain scores recorded in the electronic medical record (EMR) using the NRS scale 0-10. A higher score indicates greater pain level. Will track scores over first 24 hours following surgery completion (as determined by PACU arrival)

Time frame: PACU arrival to 24 hours postoperative

Time in PACU

Will measure duration of time patient spends in the PACU (measured in hours)

Time frame: PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.

Hospital Length of Stay

Duration of time the patient spends in the hospital. Measured in days

Time frame: Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively

Incidence of respiratory depression

The incidence of respiratory depression would be defined by any of the following: * respiratory rate \< 10 breaths/min for \>5 min * SpO₂ \< 90% for \>5 min (SpO₂ \<88% if history of COPD) * PaCO₂ \> 50 mmHg AND increased more than 20% of baseline (if baseline known) * Naloxone use postoperatively The following events will be documented in the electronic medical record (EMR) and study personnel will chart review for documented incidence of the criteria above and report findings. Will be reported as a "yes" or "no".

Time frame: Measured from time of PACU admission until 72 hours postoperatively.

Incidence of Postoperative nausea and vomiting

Incidence of postoperative nausea or vomiting will be recorded in the electronic medical record (EMR) and study personnel will chart review for documented incidence of postoperative nausea or vomiting during the first 72 hours postoperatively.

Time frame: Assessed postoperatively up to 72 hours after documented PACU admission time

Patient Satisfaction

Patient satisfaction survey will be administered by study staff 24 hours postoperatively to measure the patient satisfaction of their postoperative pain management. The survey will measure the following over the 24 postoperatively: the patients pain level on a scale from 1-10, their pain control adequacy from very poorly to very well, functional impact on getting out of bed, walking, deep breathing/coughing, physical therapy, sleeping or none, side effects of opioids including: nausea, vomiting, itching, constipation, excessive sleepiness, dizziness, or confusion, and their satisfaction level of pain management from very dissatisfied to very satisfied.

Time frame: Postoperative until 24 hours postoperative

Methadone for Post-operative Spine Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes