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Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

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ClinicalTrials.gov Identifier: NCT03529032
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Philipp Bühler, MD, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Methadone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Fentanyl group
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
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
methadone for control postoperative pain




Primary Outcome Measures :
  1. Difference of postoperative morphine consumption [ Time Frame: first 48 hours postoperatively ]
    Difference in milligrams of morphine used as rescue by patient controlled analgesia pump


Secondary Outcome Measures :
  1. Difference in pain scores, using the Numeric Rating Scale [ Time Frame: first 72 hours postoperatively ]
    Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529032


Locations
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Switzerland
Kantonsspital Baden
Baden, Kanton Aargau, Switzerland, 5404
Sponsors and Collaborators
Kantonsspital Baden
Investigators
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Principal Investigator: Philipp Buehler, MD Kantonsspital Baden
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Responsible Party: Philipp Bühler, MD, MD, Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT03529032    
Other Study ID Numbers: Ref.Nr.EK:2011/052
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Keywords provided by Philipp Bühler, MD, Kantonsspital Baden:
methadone
postoperative pain
acute pain therapy
postoperative pain therapy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents