Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.

Detailed Description
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Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.

Official Title
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A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Methadone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. german speaking patients Exclusion Criteria: patients including other studies pregnant breast feeding patients in methadone substitution therapy dependent drug user patients with BMI greater than 36kg/m2 patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L patients with liver insufficiency or failure alcoholics patients with acute heard attack

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fentanyl group<br>Drug: Fentanyl Fentanyl group 3µg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60. | |
| Experimental: methadone group<br>Drug: methadone methadone group 0.2mg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60. | Drug: Methadone<br>* methadone for control postoperative pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of postoperative morphine consumption | Difference in milligrams of morphine used as rescue by patient controlled analgesia pump | first 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain scores, using the Numeric Rating Scale | Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative. | first 72 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methadone, postoperative pain, acute pain therapy, postoperative pain therapy