Using rectal Methadone for pain management after spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the feasibility of using rectal Methadone to manage postoperative pain in adult patients undergoing spinal surgery. Participants will be randomly assigned to receive either Methadone or a placebo during their surgery, with the primary focus on recruitment success and adherence. Secondary outcomes will assess pain intensity, opioid use, and recovery quality over a follow-up period of 30 days. The study aims to determine if rectal Methadone can effectively reduce pain and improve recovery compared to standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years old or older
2. Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
3. Capacity to provide informed consent
4. For participants of childbearing potential, use of contraception.

Exclusion Criteria:

1. American Society of Anesthesiologists Physical Status \> IV
2. Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
3. Pregnant or nursing participants
4. Known or suspected mechanical gastrointestinal obstruction
5. Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
6. Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
7. Severe central nervous system depression, increased intracranial pressure, or head injury
8. Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment
9. Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins
10. Preoperative renal insufficiency or failure
11. Significant liver disease (cirrhosis or hepatic failure)
12. History of opioid use disorder within the last 3 months
13. Patients taking more than 90 mg of morphine equivalents daily
14. Poor comprehension of the English language
15. Patients who are likely to remain intubated postoperatively
16. QT interval \> 500ms on preoperative ECG

Where it's running

• St. Michael's Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sergio Pereira, MD PhD — St. Michael's Hospital. Unity Health Toronto
• Study coordinator: Sergio Pereira, MD PhD
• Email: Sergio.Pereira@unityhealth.to
• Phone: 416-360-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Spinal anesthesia success in people with prior lower back surgery

  This study will see if having previous lumbar spine surgery changes how well spinal anesthesia works on the first needle attempt in adults undergoing surgery.

  Recruiting Taksim Egitim ve Arastirma Hastanesi · Istanbul · NCT07852767

• Post-Vasectomy Pain Management Aftercare

  This study tests four pain-control regimens after vasectomy to see which helps men feel better and how much pain relief they get.

  Recruiting at 2 sites Phase 1 Columbia University · New York, New York and 1 other locations · NCT07824258

• Regular Diet After Colon Surgery

  This pilot test will see if going back to a normal, non-restricted diet after colorectal surgery is safe and feasible for adults.

  Recruiting Weill Medical College of Cornell University · New York, New York · NCT07540845

• Cryo-freezing of chest nerves to reduce pain after double lung transplant

  This tests whether freezing the nerves around the chest incision during double lung transplant helps adults need fewer opioid pain medicines and recover faster.

  Recruiting University of California, Los Angeles · Los Angeles, California and 2 other locations · NCT07281118

• Methadone to reduce long-term opioid use after major spine surgery

  This pilot trial will test whether a short course of postoperative oral methadone can help adults having multilevel lumbar or thoracic spine fusion use fewer opioids three months after surgery.

  Recruiting Phase 4 The Cleveland Clinic · Cleveland, Ohio · NCT07222072

• Nd:YAG laser to improve gum healing after tooth extraction and ridge preservation

  This test tries whether multiple Nd:YAG low-level laser sessions after tooth extraction and alveolar ridge preservation help adults heal faster and have less pain.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07095556

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.