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| Name | Class |
|---|---|
| AFP Innovation Fund | OTHER |
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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:
Participants will:
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.
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
Masking Participants and Outcome Assessors
Study Intervention:
Follow-Up: Postoperative days 1, 2, 3, and 30
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm with Methadone | Experimental | During the spinal surgery intervention, participants receive a single dose of 0.2mg/kg of Methadone rectally, after anesthesia induction. |
|
| Placebo arm | Placebo Comparator | During the spinal surgery intervention, participants receive a single dose of saline solution rectally after anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Methadone administer during spinal surgery | Drug | Rectal Methadone administered during spinal surgery for post-operative pain management |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility to recruit 40 participants into a trial of methadone and placebo | Recruitment rate (Acceptability and feasibility study) | 18 months |
| Feasibility to recruit 40 participants into a trial of methadone and placebo | Withdrawal rate (Acceptability and feasibility study) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse outcomes | Rate of postoperative respiratory depression | At 24, 48, and 72 hours post operative |
| Adverse outcomes | Rate of postoperative ileus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Pereira, MD PhD | Contact | 416-360-4000 | 49308 | Sergio.Pereira@unityhealth.to |
| Janneth A Pazmino-Canizares, MSc | Contact | 4168646060 | 49561 | Janneth.Pazmino-Canizares@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Sergio Pereira, MD PhD | St. Michael's Hospital. Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15255797 | Background | Dale O, Sheffels P, Kharasch ED. Bioavailabilities of rectal and oral methadone in healthy subjects. Br J Clin Pharmacol. 2004 Aug;58(2):156-62. doi: 10.1111/j.1365-2125.2004.02116.x. | |
| 28418966 | Background | Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609. |
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This is a feasibility pilot trial only.
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Randomized, placebo control trial
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| Placebo: Rectal saline solution | Other | Placebo: Rectal saline solution single dose received during surgery |
|
| At 24, 48, and 72 hours post operative |
| Opioid reduction | Total morphine equivalent used | At 24, 48, and 72 hours post operative |
| Pain intensity after surgery | 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) | At 24, 48, and 72 hours post operative |
| Quality of Recovery | 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. | At 24, 48, and 72 hours post operative |
| Pain interference | 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) | Difference between Baseline and 30 days after surgery |
| 31743194 | Background | Machado FC, Vieira JE, de Orange FA, Ashmawi HA. Intraoperative Methadone Reduces Pain and Opioid Consumption in Acute Postoperative Pain: A Systematic Review and Meta-analysis. Anesth Analg. 2019 Dec;129(6):1723-1732. doi: 10.1213/ANE.0000000000004404. |
| 31939849 | Background | Murphy GS, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Dickerson D, Bilimoria S, Benson J, Maher CE, Trenk GJ, Teister KJ, Szokol JW. Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery. Anesthesiology. 2020 Feb;132(2):330-342. doi: 10.1097/ALN.0000000000003025. |
| 30323647 | Background | Machado FC, Palmeira CCA, Torres JNL, Vieira JE, Ashmawi HA. Intraoperative use of methadone improves control of postoperative pain in morbidly obese patients: a randomized controlled study. J Pain Res. 2018 Oct 2;11:2123-2129. doi: 10.2147/JPR.S172235. eCollection 2018. |
| 20418538 | Background | Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24. |
| 8747759 | Background | Elliott K, Kest B, Man A, Kao B, Inturrisi CE. N-methyl-D-aspartate (NMDA) receptors, mu and kappa opioid tolerance, and perspectives on new analgesic drug development. Neuropsychopharmacology. 1995 Dec;13(4):347-56. doi: 10.1016/0893-133X(95)00083-P. |
| 18443635 | Background | Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. |
| 22227789 | Background | American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available. |
| 28893756 | Background | Weir S, Samnaliev M, Kuo TC, Ni Choitir C, Tierney TS, Cumming D, Bruce J, Manca A, Taylor RS, Eldabe S. The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). BMJ Open. 2017 Sep 11;7(9):e017585. doi: 10.1136/bmjopen-2017-017585. |
| 23392233 | Background | Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. |
| 29026331 | Background | Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017. |
| 25680636 | Background | Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF, Gottschalk A. Analgesic therapy for major spine surgery. Neurosurg Rev. 2015 Jul;38(3):407-18; discussion 419. doi: 10.1007/s10143-015-0605-7. Epub 2015 Feb 14. |