Opioid UseNCT06985069
Outcome of Multimodal Anesthesia Bern
A study testing General anesthesia applying multimodal anesthesia and General anesthesia using conventional opioid-based regimen in people with Opioid Use and Pain, Postoperative, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In the context of the ongoing opioid crisis in the USA and Europe, reducing perioperative opioid use is a growing priority. Multimodal anesthesia (MMA) offers a patient-centered alternative to opioid-free anesthesia, combining regional techniques, non-opioid analgesics, and adjunct therapies to enhance pain control… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Pain, Postoperative, Postoperative Complications
- What is being tested?
- General anesthesia applying multimodal anesthesia and General anesthesia using conventional opioid-based regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jun 2025to 18 Sep 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Existing informed consent
- German, Italian or French speaking
- Age 18 or more
- Planned duration of surgery 60min or more
- Inpatients and postoperative transfer to PACU or 24h ICU
Who cannot join
- Palliative or emergency procedures
- Reoperation (e.g. 2nd look)
- Bariatric surgery patients
- Pregnancy / breastfeeding
- Adults legally protected
- Known allergy or contraindication to interventional medication
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial
In the context of the ongoing opioid crisis in the USA and Europe, reducing perioperative opioid use is a growing priority. Multimodal anesthesia (MMA) offers a patient-centered alternative to opioid-free anesthesia, combining regional techniques, non-opioid analgesics, and adjunct therapies to enhance pain control while minimizing opioid reliance. By targeting multiple pain pathways, MMA can improve recovery outcomes, reduce side effects, and optimize resource use, representing a potential paradigm shift in perioperative medicine.
This study compares (patient-centered) outcomes after application of MMA (a standardized combination of Magnesium, Ketamine, Lidocain and Dexmedetomidine before and during surgery in combination with opioids) with an opioid based general anesthesia regimen in the context of major surgery.
- Being tested
- General anesthesia applying multimodal anesthesia, General anesthesia using conventional opioid-based regimen
- Keywords
- Multimodal anesthesia
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia applying multimodal anesthesiaProcedure or surgery
In the multimodal anesthesia-group a combination of different opioid-sparing drugs are added for general anesthesia, dosages are as follows:
- Magnesium 2g IV
- Dexmedetomidine IV 0.3mcg/kg IBW bolus over 10 minutes, followed by 0.3mcg/kg IBW until 30 min. before the end of surgery or the maximal dosage of 1.4mcg/kg IBW.
- Ketamine IV 0.3mg/kg IBW bolus, followed by 0.3 mg/kg IBW or a max. Dose of 25mg/h, until 30 min. before the end of surgery.
- Lidocaine IV 1mg/kg IBW bolus, followed by 1mg/kg/h IBW until in PACU/ICU
General anesthesia using conventional opioid-based regimenProcedure or surgery
Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist
| Study group | Role | What they receive |
|---|---|---|
| Multimodal anesthesia-group | Experimental | The intervention consists of the application of a standardized combination of Magnesium, Ketamine, Lidocaine and Dexmedetomidine before and during surgery in combination with opioids (Fentanyl, Methadone, and Hydromorphon) in a non-standardized fashion for perioperative pain control. Receives: Procedure: General anesthesia applying multimodal anesthesia |
| Opioid based-group | Active comparator | Patients in the control group will be treated with opioids only (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist for perioperative pain control. Receives: Procedure: General anesthesia using conventional opioid-based regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)
QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
Measured: Postoperative day 1
Secondary outcomes (13)
Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)
QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
Measured: Postoperative day 2
Safety outcome 1a respiratory: respiratory rate
Number of patients with reported respiratory rate of less than 8 per minute
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 1b respiratory: airway obstruction needing an intervention
Number of patients with reported airway obstruction needing an intervention (e.g. insertion of a naso-pharyngeal-tube)
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 1c respiratory: desaturation
Number of patients with reported desaturation (peripheral oxygen saturation < 92%) despite administration of nasal oxgen (max. 6l/min.)
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2a cardiac: hypotension
Number of patients with reported hypotension needing an intervention
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2b cardiac: bradycardia
Number of patients with reported heart rate lower than 60 beats per minute needing an intervention
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2c cardiac: conduction block
Number of patients with a postoperatively new reported conduction block
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 1: pain scores measured by numeric rating scale (NRS)
NRS ranging from 0 to 10, with higher scores corresponding to more postoperative pain
Measured: At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC)
Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)
RASS ranging from -5 until +4 with negative values corresponding to progressive sedation, positive values corresponding to progressive delirium
Measured: Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 3: severity of postoperative nausea and vomiting
percentage of patients with either:
- no nausea
- nausea without vomiting
- nausea with vomiting
- >3 times vomiting in 30 minutes
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 4: oxygen use
Maximal administered oxygen ([l/min.]
Measured: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Opioid consumption in the post-operative period
Oral morphine milligram equivalents mg
Measured: First 48 hours postoperatively
Impact on long-term opioid use after hospital discharge
Percentage of patients with a new opioid prescription after hospital discharge
Measured: Hospital discharge (expected up to 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start16 Jun 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wüthrich, Professor, Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985069
- Sponsor's protocol ID
- MMA 25-01
- Other IDs
- 2025-00283, 2025
- Status last verified
- Nov 2025
- First submitted
- 6 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial
- ClinicalTrials.gov ID
- NCT06985069
- Acronym / sponsor ID
- MMA 25-01
- Keywords
- Multimodal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 22 May 2025 (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.
In the context of the ongoing opioid crisis in the USA and Europe, reducing perioperative opioid use is a growing priority. Multimodal anesthesia (MMA) offers a patient-centered alternative to opioid-free anesthesia, combining regional techniques, non-opioid analgesics, and adjunct therapies to enhance pain control while minimizing opioid reliance. By targeting multiple pain pathways, MMA can improve recovery outcomes, reduce side effects, and optimize resource use, representing a potential paradigm shift in perioperative medicine.
This study compares (patient-centered) outcomes after application of MMA (a standardized combination of Magnesium, Ketamine, Lidocain and Dexmedetomidine before and during surgery in combination with opioids) with an opioid based general anesthesia regimen in the context of major surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multimodal anesthesia-group | Experimental | Procedure: General anesthesia applying multimodal anesthesiaThe intervention consists of the application of a standardized combination of Magnesium, Ketamine, Lidocaine and Dexmedetomidine before and during surgery in combination with opioids (Fentanyl, Methadone, and Hydromorphon) in a non-standardized fashion for perioperative pain control. |
| Opioid based-group | Active comparator | Procedure: General anesthesia using conventional opioid-based regimenPatients in the control group will be treated with opioids only (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist for perioperative pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Existing informed consent
- German, Italian or French speaking
- Age 18 or more
- Planned duration of surgery 60min or more
- Inpatients and postoperative transfer to PACU or 24h ICU
Key exclusion criteria (6 listed)
- Palliative or emergency procedures
- Reoperation (e.g. 2nd look)
- Bariatric surgery patients
- Pregnancy / breastfeeding
- Adults legally protected
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 |
|---|---|---|
| General anesthesia applying multimodal anesthesiaIn the multimodal anesthesia-group a combination of different opioid-sparing drugs are added for general anesthesia, dosages are as follows: * Magnesium 2g IV * Dexmedetomidine IV 0.3mcg/kg IBW bolus over 10 minutes, followed by 0.3mcg/kg IBW until 30 min. before the end of surgery or the maximal dosage of 1.4mcg/kg IBW. * Ketamine IV 0.3mg/kg IBW bolus, followed by 0.3 mg/kg IBW or a max. Dose of 25mg/h, until 30 min. before the end of surgery. * Lidocaine IV 1mg/kg IBW bolus, followed by 1mg/kg/h IBW until in PACU/ICU | Procedure or surgery | Multimodal anesthesia-group |
| General anesthesia using conventional opioid-based regimenOpioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist | Procedure or surgery | Opioid based-group |
Primary outcome
Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)
Time frame: Postoperative day 1
QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
13 secondary outcomes
Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)
Time frame: Postoperative day 2
Safety outcome 1a respiratory: respiratory rate
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 1b respiratory: airway obstruction needing an intervention
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 1c respiratory: desaturation
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2a cardiac: hypotension
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2b cardiac: bradycardia
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2c cardiac: conduction block
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 1: pain scores measured by numeric rating scale (NRS)
Time frame: At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC)
Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)
Time frame: Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 3: severity of postoperative nausea and vomiting
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 4: oxygen use
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Opioid consumption in the post-operative period
Time frame: First 48 hours postoperatively
Impact on long-term opioid use after hospital discharge
Time frame: Hospital discharge (expected up to 3 weeks)
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Patrick Wüthrich, Professor study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia applying multimodal anesthesia and General anesthesia using conventional opioid-based regimen in people with Opioid Use and Pain, Postoperative, run by Insel Gruppe AG, University Hospital Bern 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 6 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 18 Nov 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?
Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions) (time frame: Postoperative day 1). 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 18 Nov 2025.