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

Analgesia Clinical Trial

— NOL_Basel  

Official title:

Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485480
• Other study ID #: 2022-00283; qu20Bandschapp
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: August 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Oliver Bandschapp
• Phone: +41 61 328 6513
• Email: oliver.bandschapp[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• conventional opioid-based group
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 group
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

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the timepoint of skin incision until skin closure (within 1 day)
Secondary	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.	Every 15 minutes in recovery until patient discharge to the ward (within 1 day)
Secondary	Amount of morphine needed	Amount of morphine needed	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	Amount of ketamine needed	Amount of ketamine needed	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	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)	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	Change in pain score at movement by numeric rating scale	Change in pain score at movement 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)	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	Quality of night's sleep	Quality of night's sleep assessed with a verbal numerical scale from 0 (very poor quality of sleep) to 10 (excellent quality of sleep)	From the first postoperative day until discharge from ward (average of 1 week)
Secondary	Occurrence of nausea and vomiting	Occurrence of postoperative nausea and vomiting (PONV)	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	Change in level of sedation	Change in level of sedation	At 4 hours and then twice daily until discharge from the ward (average of 1 week)
Secondary	Perceived quality of recovery by QoR40 questionnaire	40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain	At the first postoperative day
Secondary	Time to return of gastrointestinal function	Time to return of gastrointestinal function as defined as the time from the end of surgery to the first passage of flatus and to the first bowel movement	From the stay in recovery before discharge from the ward (average of 1 week)
Secondary	Time to return of spontaneous micturition	Time to return of spontaneous micturition	From the stay in recovery before discharge from the ward (average of 1 week)