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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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).

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Interventions

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Methadone

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes