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Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Methadone
Sponsored by
Kantonsspital Baden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring methadone, postoperative pain, acute pain therapy, postoperative pain therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Baden

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Fentanyl group

methadone group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference of postoperative morphine consumption
Difference in milligrams of morphine used as rescue by patient controlled analgesia pump

Secondary Outcome Measures

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.

Full Information

First Posted
July 12, 2013
Last Updated
June 30, 2018
Sponsor
Kantonsspital Baden
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1. Study Identification

Unique Protocol Identification Number
NCT03529032
Brief Title
Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.
Official Title
A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Baden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
methadone, postoperative pain, acute pain therapy, postoperative pain therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl group
Arm Type
No Intervention
Arm Description
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.
Arm Title
methadone group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
methadone for control postoperative pain
Primary Outcome Measure Information:
Title
Difference of postoperative morphine consumption
Description
Difference in milligrams of morphine used as rescue by patient controlled analgesia pump
Time Frame
first 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Difference in pain scores, using the Numeric Rating Scale
Description
Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative.
Time Frame
first 72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Buehler, MD
Organizational Affiliation
Kantonsspital Baden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
State/Province
Kanton Aargau
ZIP/Postal Code
5404
Country
Switzerland

12. IPD Sharing Statement

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Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

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