Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy

NCT03908060 | Unknown

• 1 other identifier: 01052019
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The role of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in patients undergoing hysterectomy remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative methadone in patients scheduled for same day hysterectomy is therefore conducted.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Opioid consumption at 24 hours after extubation (cumulative opioid consumption)

  cumulative opioid consumption in oral morphine equivalents

  24 hours

• Opioid consumption at 6 hours after extubation (cumulative opioid consumption)

  cumulative opioid consumption in oral morphine equivalents

  6 hours

Secondary Outcomes (2)

• Pain intensity (NRS, 0-10) at rest and coughing

  0-48 hours after extubation

• Postoperative side effects/ adverse events (nausea and vomiting, sedation, hypoventilation, and hypoxemia)

  0-72 hours after extubation

Study Arms (2)

Intravenous single-dose methadone

EXPERIMENTAL

A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.2 mg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (height (cm) - 105).

Drug: Methadone

Intravenous single-dose morphine

ACTIVE COMPARATOR

A 10 ml syringe with 2 mg/ml of morphine will be prepared and study drug will be administered as intravenous bolus dose (0.2 mg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (height (cm) - 105).

Drug: Morphine

Interventions

Methadone DRUG

One intravenous administration of methadone (0.2 mg/kg ideal body weight)

Intravenous single-dose methadone

Morphine DRUG

One intravenous administration of morphine (0.2 mg/kg ideal body weight)

Intravenous single-dose morphine

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients scheduled for elective laparoscopic hysterectomy for benign indications

You may not qualify if:

• American Society of Anaesthesiologists (ASA) physical status IV or V
• prolonged QT-interval assessed by electrocardiogram (\> 440 milliseconds)
• Existing treatment with medications prolonging the QT-interval
• Hysterectomy due to malignancy or acute bleeding disorders
• Allergy to study drugs
• Preoperative daily use of opioids
• Severe respiratory insufficiency
• Heart failure
• Acute alcohol intoxication/delirium tremens
• Increased intracranial pressure
• Acute liver disease
• Acute abdominal pain
• Liver insufficiency
• Kidney insufficiency
• Treatment with rifampicin

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital

Horsens, Central Jutland, 8700, Denmark

Location

Related Publications (6)

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.

  PMID: 25837528 BACKGROUND

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.

  PMID: 28418966 BACKGROUND

• Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

  PMID: 20418538 BACKGROUND

• Richlin DM, Reuben SS. Postoperative pain control with methadone following lower abdominal surgery. J Clin Anesth. 1991 Mar-Apr;3(2):112-6. doi: 10.1016/0952-8180(91)90007-a.

  PMID: 2039637 BACKGROUND

• Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.

  PMID: 1609941 BACKGROUND

• Friesgaard KD, Brix LD, Kristensen CB, Rian O, Nikolajsen L. Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial. BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep.

  PMID: 37638083 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kristian Friesgaard, MD, PhD

  Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: May 6, 2019
• Primary Completion: July 8, 2022
• Study Completion: December 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)