Post-operative Care, Post-operative Pain Management, Spinal Surgery
Conditions
Keywords
Intraoperative Methadone, Rectal Methadone administration, spinal surgery post-operative pain management
Brief summary
Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery. The main questions are: 1. Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial? 2. Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management. Participants will: * receive either Methadone or placebo during surgery. * be asked some questions about their pain during days 1 to 3 after surgery * be contacted by phone to ask about their recovery At this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.
Detailed description
Indication: Adult patients undergoing spine surgery Condition: Perioperative pain management Number of participants 40 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome 1) Average pain intensity; 2) Rate of respiratory depression and postoperative ileus; 3) Use of opioids in morphine equivalents; 4) Quality of recovery Study design * Interventional trial * Allocation: Randomized * Intervention model: 2-Arm Parallel-Group * Primary purpose: Feasibility * Phase: Phase IV Masking Participants and Outcome Assessors Study Intervention: * Intervention Arm: Methadone 0.2mg/kg of ideal body weight via rectal administration + standard or care * Placebo Arm: Saline solution via rectal administration + standard of care Follow-Up: Postoperative days 1, 2, 3, and 30
Interventions
DRUGRectal Methadone administer during spinal surgery
Rectal Methadone administered during spinal surgery for post-operative pain management
OTHERPlacebo: Rectal saline solution
Placebo: Rectal saline solution single dose received during surgery
Sponsors
AFP Innovation Fund
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, placebo control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 65 years-old. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to recruit 40 participants into a trial of methadone and placebo | 18 months | Recruitment rate (Acceptability and feasibility study) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid reduction | At 24, 48, and 72 hours post operative | Total morphine equivalent used |
| Adverse outcomes | At 24, 48, and 72 hours post operative | Rate of postoperative respiratory depression |
| Pain intensity after surgery | At 24, 48, and 72 hours post operative | Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, Pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity) |
| Quality of Recovery | At 24, 48, and 72 hours post operative | Quality of Recovery (QoR-15) Score, 15 items are rated on a 0-10 scale, with the total possible score ranging from 0 to 150, where higher scores indicate better recovery. |
| Pain interference | Difference between Baseline and 30 days after surgery | Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. 6 items, 5 Likert scale (the higher the score the higher the interference from pain) |
Countries
Canada
Contacts
Primary ContactSergio Pereira, MD PhD
Backup ContactJanneth A Pazmino-Canizares, MSc
Outcome results
None listed