Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

NCT03529032 | Completed Phase 4 DMC

• 1 other identifier: Ref.Nr.EK:2011/052
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

methadone; postoperative pain; acute pain therapy; postoperative pain therapy

Outcome Measures

Primary Outcomes (1)

• Difference of postoperative morphine consumption

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

  first 48 hours postoperatively

Secondary Outcomes (1)

• Difference in pain scores, using the Numeric Rating Scale

  first 72 hours postoperatively

Study Arms (2)

Fentanyl group

NO INTERVENTION

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.

methadone group

EXPERIMENTAL

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

Interventions

Methadone DRUG

methadone for control postoperative pain

methadone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Baden: lead

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Philipp Buehler, MD

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: May 18, 2018
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: May 1, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

CH (1)