Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Methadone

• Registration Number: NCT03529032
• Lead Sponsor: Kantonsspital Baden

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-07
• Study First Submitted: 2013-07-12
• Study Completion: 2018-05
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-30
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methadone group	Methadone	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.

Primary Outcome Measures

Name	Time	Method
Difference of postoperative morphine consumption	first 48 hours postoperatively	Difference in milligrams of morphine used as rescue by patient controlled analgesia pump

Secondary Outcome Measures

Name	Time	Method
Difference in pain scores, using the Numeric Rating Scale	first 72 hours postoperatively	Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative.

Trial Locations

Locations (1)

Kantonsspital Baden; 🇨🇭 Baden, Kanton Aargau, Switzerland