Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy
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|ClinicalTrials.gov Identifier: NCT03908060|
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Methadone Drug: Morphine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|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.|
|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|
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).
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).
One intravenous administration of morphine (0.2 mg/kg ideal body weight)
- Opioid consumption at 24 hours after extubation (cumulative opioid consumption) [ Time Frame: 24 hours ]cumulative opioid consumption in oral morphine equivalents
- Opioid consumption at 6 hours after extubation (cumulative opioid consumption) [ Time Frame: 6 hours ]cumulative opioid consumption in oral morphine equivalents
- 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)
- Postoperative side effects/ adverse events (nausea and vomiting, sedation, hypoventilation, and hypoxemia) [ Time Frame: 0-72 hours after extubation ]Number of patients
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
|Contact: Kristian Friesgaard, MD, PhDemail@example.com|
|Contact: Lone Dragnes Brix, MHSc, PhDfirstname.lastname@example.org|
|Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital||Recruiting|
|Horsens, Central Denmark Region, Denmark, 8700|
|Contact: Lone Dragnes Brix, MHSc, PhD 004541679353 email@example.com|
|Contact: Omar Rian, MD 004524201060 firstname.lastname@example.org|
|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|
|Principal Investigator:||Kristian Friesgaard, MD, PhD||Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital|