BridgeMD
New treatment option for Spinal Surgery
Official title Perioperative Rectal Methadone in Spine Surgery
ClinicalTrials.gov ID: NCT06843174
What this study is testing
What is Rectal Methadone administer during spinal surgery?
Rectal Methadone administer during spinal surgery is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for spinal surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 18 to 65 years-old.
- Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
- Capacity to provide informed consent
- For participants of childbearing potential, use of contraception.
You likely can't join if
- American Society of Anesthesiologists Physical Status \> IV
- Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
- Pregnant or nursing participants
- Known or suspected mechanical gastrointestinal obstruction
- Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
- Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
See the full eligibility criteria
- 18 to 65 years-old.
- Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
- Capacity to provide informed consent
- For participants of childbearing potential, use of contraception.
- American Society of Anesthesiologists Physical Status \> IV
- Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
- Pregnant or nursing participants
- Known or suspected mechanical gastrointestinal obstruction
- Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
- Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
- Severe central nervous system depression, increased intracranial pressure, or head injury
- Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment
- Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins
- Preoperative renal insufficiency or failure
- Significant liver disease (cirrhosis or hepatic failure)
- History of opioid use disorder within the last 3 months
- Patients taking more than 90 mg of morphine equivalents daily
- Poor comprehension of the English language
- Patients who are likely to remain intubated postoperatively
- QT interval \> 500ms on preoperative ECG
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.