Methadone in Ambulatory Surgery

Study Overview
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Brief Summary
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The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.

Official Title
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Methadone in Ambulatory Surgery

Conditions
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Post-operative Pain, Anesthesia

Intervention / Treatment
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* Drug: methadone
* Drug: Control (Intra-operative administration of opioids, other than methadone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours Signed, written, informed consent Exclusion Criteria: History of or known liver or kidney disease. Females who are pregnant or nursing. Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches) History of allergy to methadone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control (Intra-operative administration of opioids, other than methadone) | Drug: Control (Intra-operative administration of opioids, other than methadone)<br>* Intra-operative administration of opioids, other than methadone<br>* Other names: morphine fentanyl;|
| Active Comparator: Treatment methadone 0.1 mg/kg<br>methadone 0.1 mg/kg | Drug: methadone<br>* Escalating dose of methadone up to .3mg/kg.<br>* Other names: Dolophine;|
| Active Comparator: Treatment methadone 0.15 mg/kg<br> | Drug: methadone<br>* Escalating dose of methadone up to .3mg/kg.<br>* Other names: Dolophine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Opioid Administration | Data on opioids administered intraoperatively will be collected from the subject's EMR. | Administered at induction of anesthesia | 
| Postoperative Opioid Administration | Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief] | EMR reviewed at 24 hours post-administration or at hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption Within First 30 Postoperative Days | Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit). | 30 days | 
| Pain Relief Within First 30 Postoperative Days | Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient's 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, morphine, methadone