AnalgesiaNOL_BaselNCT05485480
Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia
A study testing conventional opioid-based group and opioid-sparing group in people with Analgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- conventional opioid-based group and opioid-sparing group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 2022to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, University Hospital Basel
Basel, 4031
About this study
Official title: Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial
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).
Read the 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.
- Conditions
- Analgesia
- Being tested
- conventional opioid-based group, opioid-sparing group
- Keywords
- analgesia nociception, opioid-sparing anaesthesia, conventional opioid-based anaesthesia, Pain Monitoring Device (PMD-200), intraoperative nociceptive levels, Post operative nausea and vomiting (PONV)
- Medical subject headings
- Agnosia, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol | Experimental | Ketamine: started at 5mg/h; continued until 30min before end of surgery, then reduced to 1mg/h until discharge from recovery.
Fentanyl: bolus of 50mcg before skin incision (in case of insufficient analgesia further boluses of 25mcg, upper limit is 100mcg).
Lidocaine: bolus of 1.5mg/kg of ideal body weight (IBW),(maximum 100mg) at induction of anaesthesia, then continuous infusion of 1.5mg/kg IBW/h (maximum 100mg/h) until discharge from recovery.
Magnesium: infusion of 2g/h for a maximum of 2h after induction of anaesthesia (maximum dose 4g). In case of bradycardia or hypotension, rate is reduced to 1g/h.
Clonidine: bolus of 15mcg if needed. Maximum amount 150mcg. Remifentanil: started at time of induction of anaesthesia until end of surgery. Receives: Drug: opioid-sparing group |
| Conventional group: Fentanyl, Remifentanil, Propofol | Active comparator | Control Intervention:
Remifentanil: Remifentanil is given as a target controlled infusion using the Minto-model. It is started at the timepoint of induction of anaesthesia and given until the end of surgery.
Fentanyl: 2mcg/kg i.v. is given at the time of induction of anaesthesia and another 1-2mcg/kg is given prior to incision. Further fentanyl boluses (1-2mcg/kg boluses) are given in case there seems to be insufficient analgesia. Receives: Drug: conventional opioid-based group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the timepoint of skin incision until skin closure (within 1 day)
Secondary outcomes (11)
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.
Measured: Every 15 minutes in recovery until patient discharge to the ward (within 1 day)
Amount of morphine needed
Amount of morphine needed
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
Amount of ketamine needed
Amount of ketamine needed
Measured: 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)
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
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)
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
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)
Measured: From the first postoperative day until discharge from ward (average of 1 week)
Occurrence of nausea and vomiting
Occurrence of postoperative nausea and vomiting (PONV)
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
Change in level of sedation
Change in level of sedation
Measured: At 4 hours and then twice daily until discharge from the ward (average of 1 week)
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
Measured: At the first postoperative day
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
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
Time to return of spontaneous micturition
Time to return of spontaneous micturition
Measured: From the stay in recovery before discharge from the ward (average of 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start17 Nov 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomised controlled non-inferiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Girard, Prof. Dr. med., Study director, Department of Anaesthesiology, University Hospital BaselOliver Bandschapp, PD Dr. med., Principal investigator, Department of Anaesthesiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485480
- Sponsor's protocol ID
- 2022-00283; qu20Bandschapp
- Acronym
- NOL_Basel
- Status last verified
- May 2025
- First submitted
- 20 Jul 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05485480
- Acronym / sponsor ID
- NOL_Basel / 2022-00283; qu20Bandschapp
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind, randomised controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol | Experimental | Drug: opioid-sparing groupKetamine: started at 5mg/h; continued until 30min before end of surgery, then reduced to 1mg/h until discharge from recovery. Fentanyl: bolus of 50mcg before skin incision (in case of insufficient analgesia further boluses of 25mcg, upper limit is 100mcg). Lidocaine: bolus of 1.5mg/kg of ideal body weight (IBW),(maximum 100mg) at induction of anaesthesia, then continuous infusion of 1.5mg/kg IBW/h (maximum 100mg/h) until discharge from recovery. Magnesium: infusion of 2g/h for a maximum of 2h after induction of anaesthesia (maximum dose 4g). In case of bradycardia or hypotension, rate is reduced to 1g/h. Clonidine: bolus of 15mcg if needed. Maximum amount 150mcg. Remifentanil: started at time of induction of anaesthesia until end of surgery. |
| Conventional group: Fentanyl, Remifentanil, Propofol | Active comparator | Drug: conventional opioid-based groupControl Intervention: Remifentanil: Remifentanil is given as a target controlled infusion using the Minto-model. It is started at the timepoint of induction of anaesthesia and given until the end of surgery. Fentanyl: 2mcg/kg i.v. is given at the time of induction of anaesthesia and another 1-2mcg/kg is given prior to incision. Further fentanyl boluses (1-2mcg/kg boluses) are given in case there seems to be insufficient analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Inability to give informed consent
- ASA status IV and V
- Pregnant or breastfeeding women
- Allergy to one of the study drugs
- Urgent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional opioid-based groupIn 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 | Drug | Conventional group: Fentanyl, Remifentanil, Propofol |
| opioid-sparing groupIn 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 | Drug | Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol |
Primary outcome
Mean of the nociception level as measured by the PMD-200
Time frame: From the timepoint of skin incision until skin closure (within 1 day)
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.
11 secondary outcomes
Change in Aldrete score
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
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
Time frame: From the stay in recovery before discharge from the ward (average of 1 week)
Quality of night's sleep
Time frame: From the first postoperative day until discharge from ward (average of 1 week)
Occurrence of nausea and vomiting
Time frame: From the stay in recovery before discharge from the ward (average of 1 week)
Change in level of sedation
Time frame: At 4 hours and then twice daily until discharge from the ward (average of 1 week)
Perceived quality of recovery by QoR40 questionnaire
Time frame: At the first postoperative day
Time to return of gastrointestinal function
Time frame: From the stay in recovery before discharge from the ward (average of 1 week)
Time to return of spontaneous micturition
Time frame: From the stay in recovery before discharge from the ward (average of 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Girard, Prof. Dr. med. study director
Department of Anaesthesiology, University Hospital Basel
Oliver Bandschapp, PD Dr. med. principal investigator
Department of Anaesthesiology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional opioid-based group and opioid-sparing group in people with Analgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of the nociception level as measured by the PMD-200 (time frame: From the timepoint of skin incision until skin closure (within 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.