Pain, PostoperativePhase 3NCT04697537
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine
A Phase 3 study testing Ultrasound guided regional anesthesia and Local infiltration analgesia in people with Pain, Postoperative and Anesthesia, Local, run by Medical University of Graz at 1 site in Austria.
Trial summary
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Local, Gonarthrosis
- What is being tested?
- Ultrasound guided regional anesthesia and Local infiltration analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2021to 9 Apr 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- non pregnant
- patients with gonarthrosis who have given written consent for participation
Who cannot join
- Age below 18 years
- pregnancy
- breast-feeding patients
- allergies against study medication
- missing or denied written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine as Adjunct Medication to Local Infiltration Anesthesia (LIA) vs Ultrasound-Guided Regional Anesthesia (USRA) in Regard to Patients' Need for Opioids, Wellbeing, Satisfaction, and Knee Functionality in Knee-endoprosthetics
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.
Read the detailed description
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.
- Conditions
- Pain, Postoperative, Anesthesia, Local, Gonarthrosis
- Being tested
- Ultrasound guided regional anesthesia, Local infiltration analgesia
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided regional anesthesiaDrug
Also called dexmedetomidine, Ropivacaine
Applied perineurally preoperatively ultrasound guided regional anesthesia
Local infiltration analgesiaDrug
Also called dexmedetomidine, Ropivacaine
Applied in the wound intraoperatively from the orthopedics
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided regional anesthesia | Active comparator | Patient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml). Receives: Drug: Ultrasound guided regional anesthesia |
| Local infiltration analgesia | Active comparator | Patient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml). Receives: Drug: Local infiltration analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of opioid consumption in oral morphine equivalent
consumed opioids in mg of oral morphine equivalent
Measured: 48 hours postoperatively
Secondary outcomes (8)
Pain assesment
Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome)
Measured: 5 days postoperatively or until discharge
Pain medication necessary
Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day
Measured: 5 days postoperatively or until discharge
Functionality of the prothesis - OKS (Oxford Knee Score)
According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome)
Measured: 5 days postoperatively or until discharge
Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)
According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome)
Measured: 5 days postoperatively or until discharge
Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome)
Measured: 5 days postoperatively or until discharge
Functionality of the prothesis- G-FJS (German Forgotten Joint Score)
According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome)
Measured: 5 days postoperatively or until discharge
Complications
Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)
Measured: 5 days postoperatively or until discharge
procedure specific time
time of the operation
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Feb 2021
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregor A Schittek, MD, Principal investigator, Med Uni Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697537
- Sponsor's protocol ID
- GAS1.0
- Status last verified
- Apr 2021
- First submitted
- 4 Jan 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as Adjunct Medication to Local Infiltration Anesthesia (LIA) vs Ultrasound-Guided Regional Anesthesia (USRA) in Regard to Patients' Need for Opioids, Wellbeing, Satisfaction, and Knee Functionality in Knee-endoprosthetics
- ClinicalTrials.gov ID
- NCT04697537
- Acronym / sponsor ID
- GAS1.0
- Conditions
- Pain, Postoperative, Anesthesia, Local, Gonarthrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 6 Jan 2021 (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.
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.
Detailed description
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided regional anesthesia | Active comparator | Drug: Ultrasound guided regional anesthesiaPatient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml). |
| Local infiltration analgesia | Active comparator | Drug: Local infiltration analgesiaPatient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- non pregnant
- patients with gonarthrosis who have given written consent for participation
Key exclusion criteria (5 listed)
- Age below 18 years
- pregnancy
- breast-feeding patients
- allergies against study medication
- missing or denied written consent
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 |
|---|---|---|
| Ultrasound guided regional anesthesiaAlso: dexmedetomidine, RopivacaineApplied perineurally preoperatively ultrasound guided regional anesthesia | Drug | Ultrasound guided regional anesthesia |
| Local infiltration analgesiaAlso: dexmedetomidine, RopivacaineApplied in the wound intraoperatively from the orthopedics | Drug | Local infiltration analgesia |
Primary outcome
Need of opioid consumption in oral morphine equivalent
Time frame: 48 hours postoperatively
consumed opioids in mg of oral morphine equivalent
8 secondary outcomes
Pain assesment
Time frame: 5 days postoperatively or until discharge
Pain medication necessary
Time frame: 5 days postoperatively or until discharge
Functionality of the prothesis - OKS (Oxford Knee Score)
Time frame: 5 days postoperatively or until discharge
Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: 5 days postoperatively or until discharge
Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 5 days postoperatively or until discharge
Functionality of the prothesis- G-FJS (German Forgotten Joint Score)
Time frame: 5 days postoperatively or until discharge
Complications
Time frame: 5 days postoperatively or until discharge
procedure specific time
Time frame: during surgery
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 14 Apr 2021.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request
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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.
Gregor A Schittek, MD principal investigator
Med Uni Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound guided regional anesthesia and Local infiltration analgesia in people with Pain, Postoperative and Anesthesia, Local, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 5 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 14 Apr 2021. 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 Austria. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Need of opioid consumption in oral morphine equivalent (time frame: 48 hours postoperatively). 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 14 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.