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The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.
Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.
Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.
Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg)
If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Experimental |
| |
| Standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Methadone 0.2 mg/kg (max 20 mg) |
| |
| Standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Opioid use in morphine equivalents (ME) | perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals) | Perioperative until 72 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in numeric rating scale (NRS) pain scores | Pain scores recorded in the electronic medical record (EMR) using the NRS scale 0-10. A higher score indicates greater pain level. Will track scores over first 24 hours following surgery completion (as determined by PACU arrival) | PACU arrival to 24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Drug |
Standard intraoperative opioid regimen (control) |
|
| Time in PACU |
Will measure duration of time patient spends in the PACU (measured in hours) |
| PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively. |
| Hospital Length of Stay | Duration of time the patient spends in the hospital. Measured in days | Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively |
| Incidence of respiratory depression | The incidence of respiratory depression would be defined by any of the following:
The following events will be documented in the electronic medical record (EMR) and study personnel will chart review for documented incidence of the criteria above and report findings. Will be reported as a "yes" or "no". | Measured from time of PACU admission until 72 hours postoperatively. |
| Incidence of Postoperative nausea and vomiting | Incidence of postoperative nausea or vomiting will be recorded in the electronic medical record (EMR) and study personnel will chart review for documented incidence of postoperative nausea or vomiting during the first 72 hours postoperatively. | Assessed postoperatively up to 72 hours after documented PACU admission time |
| Patient Satisfaction | Patient satisfaction survey will be administered by study staff 24 hours postoperatively to measure the patient satisfaction of their postoperative pain management. The survey will measure the following over the 24 postoperatively: the patients pain level on a scale from 1-10, their pain control adequacy from very poorly to very well, functional impact on getting out of bed, walking, deep breathing/coughing, physical therapy, sleeping or none, side effects of opioids including: nausea, vomiting, itching, constipation, excessive sleepiness, dizziness, or confusion, and their satisfaction level of pain management from very dissatisfied to very satisfied. | Postoperative until 24 hours postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |