Clinical trial NCT05485480: Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia
Official title: Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: analgesia nociception
opioid-sparing anaesthesia
conventional opioid-based anaesthesia
Pain Monitoring Device (PMD-200)
intraoperative nociceptive levels
Post operative nausea and vomiting (PONV)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomised controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean of the nociception level as measured by the PMD-200
timeFrame: From the timepoint of skin incision until skin closure (within 1 day)
Secondary outcomes:
measure: Change in Aldrete score
timeFrame: Every 15 minutes in recovery until patient discharge to the ward (within 1 day)
measure: Amount of morphine needed
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Amount of ketamine needed
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Change in pain score at rest by numeric rating scale
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Change in pain score at movement by numeric rating scale
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Quality of night's sleep
timeFrame: From the first postoperative day until discharge from ward (average of 1 week)
measure: Occurrence of nausea and vomiting
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Change in level of sedation
timeFrame: At 4 hours and then twice daily until discharge from the ward (average of 1 week)
measure: Perceived quality of recovery by QoR40 questionnaire
timeFrame: At the first postoperative day
measure: Time to return of gastrointestinal function
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
measure: Time to return of spontaneous micturition
timeFrame: From the stay in recovery before discharge from the ward (average of 1 week)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesiology, University Hospital Basel
Study officials:
affiliation: Department of Anaesthesiology, University Hospital Basel
name: Thierry Girard, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology, University Hospital Basel
name: Oliver Bandschapp, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: