Methadone for Post-operative Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone, Standard of care.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery
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.
Interventions
- Drug Methadone
Methadone 0.2 mg/kg (max 20 mg) - Drug Standard of care
Standard intraoperative opioid regimen (control)
Primary outcome measures
- Perioperative Opioid use in morphine equivalents (ME) [Time frame: Perioperative until 72 hours postoperative]
Secondary outcome measures (6)
- Change in numeric rating scale (NRS) pain scores [Time frame: PACU arrival to 24 hours postoperative]
- Time in PACU [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 [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 [Time frame: Measured from time of PACU admission until 72 hours postoperatively.]
- Incidence of Postoperative nausea and vomiting [Time frame: Assessed postoperatively up to 72 hours after documented PACU admission time]
- Patient Satisfaction [Time frame: Postoperative until 24 hours postoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT07517679 · 111197