Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia

University Hospital, Basel, Switzerland70 enrolled

Overview

The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200).

Opioids have been an integral part of general anaesthesia. They are effective in preventing perception of noxious stimuli and ensure intraoperative haemodynamic stability. However, opioids are associated with a number of unwanted side effects (e.g. nausea and vomiting, sedation, ileus, respiratory depression, increased postoperative pain and morphine consumption and hyperalgesia). To minimise these side effects, there has been an interest in developing opioid-sparing anaesthesia protocols. Recently, analgesia nociception monitoring devices have become available. The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200). Patients scheduled to receive general surgical, gynaecological or urological laparoscopic surgery will be randomised into one of the two study groups. Study group A will be anaesthetised with an opioid-sparing protocol and study group B will be anaesthetised with a conventional opioid-based protocol. Intraoperative nociception will be evaluated with PMD-200. Postoperative visits will take place in recovery, 4-5h after surgery and then twice a day. In recovery, the amount of opioids and ketamine needed, pain, postoperative nausea and vomiting (PONV) and the time until the patient is fit for discharge according to the Aldrete score will be assessed. At the 4-5h postoperative visit, the amount of opioids and ketamine needed, maximum pain at rest and at mobilisation, incidence of PONV, mobilisation, micturition and sedation level will be assessed. At the twice daily follow up visits, amount of opioids and other analgesic drugs needed, pain at rest and at mobilisation, gastrointestinal function, quality of night's sleep, incidence of PONV, level of sedation and fitness for discharge home will be assessed. On day one after surgery, the perceived quality of recovery will be assessed with the QoR40 questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Analgesia

Interventions

conventional opioid-based groupDRUG

In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the conventional opioid-based group will receive the following drugs: Remifentanil and Fentanyl

opioid-sparing groupDRUG

In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the opioid-sparing group will receive Ketamine, Fentanyl, Lidocaine, Magnesium, Clonidine, Remifentanil

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed Consent as documented by signature * Age older than 18 years * Ability to give informed consent * Undergoing scheduled general surgical, gynaecological or urological laparoscopic surgery * American Society of Anesthesiology Score (ASA) status I, II, III Exclusion Criteria: * Inability to give informed consent * ASA status IV and V * Pregnant or breastfeeding women * Allergy to one of the study drugs * Urgent surgery * Surgery with planned regional anaesthesia * Outpatient surgery * Atrioventricular block, intraventricular or sinoatrial block * Atrial fibrillation * Sinus bradycardia * Cardiac insufficiency with a reduced left ventricular ejection fraction of below 40% * Coronary artery disease * Epilepsy * Liver cirrhosis * Chronic kidney disease (Clearance \< 50ml/h) * Chronic opioid therapy * Chronic pain

Locations (1)

Department of Anaesthesiology, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Mean of the nociception level as measured by the PMD-200

The PMD-200 device consists of a finger probe which continuously assesses pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, skin conductance fluctuations, skin temperature, and finger motion. A value of 0 corresponds to no pain and a value of 100 to maximal pain. A value will be measured every minute from the timepoint of skin incision until skin closure.

Time frame: From the timepoint of skin incision until skin closure (within 1 day)

Secondary Outcomes

Change in Aldrete score

Fitness for discharge to ward is checked every 15 minutes with the Aldrete score. The Aldrete score assigned a number of 0, 1, or 2 to 5 variables: activity, respiration, circulation, consciousness, and color. A score of 9 out of 10 is considered adequate for discharge from the recovery.

Time frame: Every 15 minutes in recovery until patient discharge to the ward (within 1 day)

Amount of morphine needed

Time frame: From the stay in recovery before discharge from the ward (average of 1 week)

Amount of ketamine needed

Time frame: From the stay in recovery before discharge from the ward (average of 1 week)

Change in pain score at rest by numeric rating scale

Change in pain score at rest by numeric rating scale (to assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable)

Time frame: From the stay in recovery before discharge from the ward (average of 1 week)

Change in pain score at movement by numeric rating scale

Data from ClinicalTrials.gov

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