Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fu… (NCT04112550) | Clinical Trial Compass
UnknownPhase 1
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
150 participantsStarted 2020-02-11
Plain-language summary
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.
Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively.
Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 - 70
* Will undergo one level minimally invasive lumbar fusion surgery
* Primary symptoms are back and/or leg pain
Exclusion Criteria:
* Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)
* Significant liver disease (cirrhosis or hepatic failure)
* American Society of Anesthesiologists (ASA) physical status IV or V
* Pulmonary disease necessitating home oxygen therapy
* Patients with acute bronchial asthma or hypercarbia
* Patient who has or is suspected of having a paralytic ileus
* Preoperative use of methadone or hydromorphone
* Known hypersensitivity to methadone
* Known hypersensitivity to oxycodone
* Recent history of opioid or alcohol abuse
* Inability to use a PCA device
* Inability to speak English
* Any patient judged by the anesthesia care team to potentially require prolonged postoperative intubation
* Participation in another clinical trial
* Inability of patient to provide study informed consent (including patients who are cognitively impaired)
* Presence of drug interaction between methadone/oxycodone and patient's regular or PRN medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.