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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908060
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Methadone Drug: Morphine Not Applicable

Detailed Description:

Background with aim: Hysterectomy is the most common major gynaecological procedure in the world and hysterectomy on benign indications are increasingly being performed as same-day surgery. Therefore, perioperative anaesthesia has moved towards the use of very short-acting opioids with the incitement to speed up extubation and facilitate hospital discharge. However, the potential consequence is that more patients experience pain and discomfort.

Methadone has several desirable pharmacological features, and a single intraoperative dose of the long acting opioid could therefore theoretically expand the analgesic window and reduce postoperative opioid consumption compared to the more conventional use of short-acting opioids. The aim of this study is to investigate the effect of a single-dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. Our primary hypothesis is that intravenous perioperative methadone reduces opioid consumption (oral cumulative equivalent dose) by 30% during the first 24 postoperative hours compared to intravenous morphine.

Methods: 126 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: an intervention arm (methadone 0.2 mg/kg ideal body weight) and a control arm (morphine 0.2 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2018-004351-20) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-365-18).

Hypothesis: The results will probably be applicable to other types of surgery involving visceral pain, and thus the present study has the potential to improve the pain management for a large number of patients undergoing surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Double-blind, Randomised Controlled Trial
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Intravenous single-dose methadone
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
One intravenous administration of methadone (0.2 mg/kg ideal body weight)

Active Comparator: Intravenous single-dose morphine
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
One intravenous administration of morphine (0.2 mg/kg ideal body weight)




Primary Outcome Measures :
  1. Opioid consumption at 24 hours after extubation (cumulative opioid consumption) [ Time Frame: 24 hours ]
    cumulative opioid consumption in oral morphine equivalents

  2. Opioid consumption at 6 hours after extubation (cumulative opioid consumption) [ Time Frame: 6 hours ]
    cumulative opioid consumption in oral morphine equivalents


Secondary Outcome Measures :
  1. Pain intensity (NRS, 0-10) at rest and coughing [ Time Frame: 0-48 hours after extubation ]
    Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)

  2. Postoperative side effects/ adverse events (nausea and vomiting, sedation, hypoventilation, and hypoxemia) [ Time Frame: 0-72 hours after extubation ]
    Number of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patients scheduled for elective laparoscopic hysterectomy for benign indications

Exclusion Criteria:

  • 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
  • Breastfeeding
  • Inability to provide informed consent.

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): NCT03908060


Contacts
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Contact: Kristian Friesgaard, MD, PhD 004525113204 k.friesgaard@me.com
Contact: Lone Dragnes Brix, MHSc, PhD 004541679353 lonebrix@rm.dk

Locations
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Denmark
Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital Recruiting
Horsens, Central Denmark Region, Denmark, 8700
Contact: Lone Dragnes Brix, MHSc, PhD    004541679353    lonebrix@rm.dk   
Contact: Omar Rian, MD    004524201060    omarrian@rm.dk   
Principal Investigator: Kristian Friesgaard, MD, PhD         
Sub-Investigator: Lone Dragnes Brix, MHSc, PhD         
Sub-Investigator: Omar Rian, MD         
Sub-Investigator: Christina Blach Kristensen, MD         
Sub-Investigator: Lone Nikolajsen, PhD, DMSc         
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Kristian Friesgaard, MD, PhD Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital
Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03908060    
Other Study ID Numbers: 01052019
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
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