Knee OsteoarthritisPhase 4NCT06470100
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty
A Phase 4 study testing 0.9% Sodium Chloride Injection, Dexamethasone and Dexmedetomidine in people with Knee Osteoarthritis and Knee Arthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis, Knee Disease
- What is being tested?
- 0.9% Sodium Chloride Injection, Dexamethasone and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 13 Aug 2024to 20 Mar 2026
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing primary hip arthroplasty
- aged >18 years and <100 years
- ASA physical status 1, 2 or 3.
Who cannot join
- if they refused to participate,
- had a history of opioid abuse,
- had an infection of the site of needle puncture,
- were less than 18 years of age,
- were postponed as having ASA 4 or 5,
- had an allergy to any of the drugs used in the study,
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- renal failure (estimated glomerular filtration rate <15ml/min/1.73m2),
- liver failure,
- known or suspected coagulopathy,
- pre-existing anatomical or neurological disorders in the lower extremities,
- intellectual disability with problems in pain evaluation,
- severe psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Total Knee Arthroplasty
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty
Read the detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for knee surgery.
After knee surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
Local anaesthesia's much lower toxicity threshold makes it essential for its safety. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Disease, Knee Pain Chronic
- Being tested
- 0.9% Sodium Chloride Injection, Dexamethasone, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called placebo erector spinae plane block
unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
DexamethasoneDrug
Also called erector spinae plane block
unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
DexmedetomidineDrug
Also called erector spinae plane block
unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 0.2% ropivacaine for erector spinae plane block Receives: Drug: 0.9% Sodium Chloride Injection |
| Dexamethasone | Experimental | 0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block Receives: Drug: Dexamethasone |
| Dexmedetomidine | Experimental | 0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after surgery
Secondary outcomes (12)
Opioid consumption
Total opioid consumption after surgery
Measured: 48 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 4 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 8 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 12 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 16 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 20 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 24 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 36 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 48 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Measured: 12 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Measured: 24 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start13 Aug 2024
- Primary completion3 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Domagalska, M.D. PhD., Study chair, Poznań University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470100
- Sponsor's protocol ID
- 107/24
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be available two years following the completion of the trial
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06470100
- Acronym / sponsor ID
- 107/24
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Disease, Knee Pain Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 24 Jun 2024 (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.
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty
Detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for knee surgery.
After knee surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
Local anaesthesia's much lower toxicity threshold makes it essential for its safety. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: 0.9% Sodium Chloride Injection0.2% ropivacaine for erector spinae plane block |
| Dexamethasone | Experimental | Drug: Dexamethasone0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing primary hip arthroplasty
- aged >18 years and <100 years
- ASA physical status 1, 2 or 3.
Key exclusion criteria (12 listed)
- if they refused to participate,
- had a history of opioid abuse,
- had an infection of the site of needle puncture,
- were less than 18 years of age,
- were postponed as having ASA 4 or 5,
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 |
|---|---|---|
| 0.9% Sodium Chloride InjectionAlso: placebo erector spinae plane blockunilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block | Drug | Control group |
| DexamethasoneAlso: erector spinae plane blockunilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block | Drug | Dexamethasone |
| DexmedetomidineAlso: erector spinae plane blockunilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block | Drug | Dexmedetomidine |
Primary outcome
first need of opiate
Time frame: 48 hours after surgery
Time after surgery when the patient needs opiate for the first time
12 secondary outcomes
Opioid consumption
Time frame: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 36 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 48 hours after surgery
Nerve damage [range 0-4]
Time frame: 12 hours after surgery
Nerve damage [range 0-4]
Time frame: 24 hours after surgery
Nerve damage [range 0-4]
Time frame: 48 hours after 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 30 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual patient data will be available two years following the completion of the trial
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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.
Malgorzata Domagalska, M.D. PhD. study chair
Poznań University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% Sodium Chloride Injection, Dexamethasone and Dexmedetomidine in people with Knee Osteoarthritis and Knee Arthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
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 12 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 30 Mar 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
first need of opiate (time frame: 48 hours after surgery). 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 30 Mar 2026.