Hip OsteoarthritisPhase 4NCT06233604
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty
A Phase 4 study testing 0.9%sodium chloride, Dexamethasone and Dexmedetomidine in people with Hip Osteoarthritis and Hip Arthropathy, 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 hip arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- What is being tested?
- 0.9%sodium chloride, Dexamethasone and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 10 Apr 2024to 15 Jul 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
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip 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 spine surgery.
After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. 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 where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae 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
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- Being tested
- 0.9%sodium chloride, Dexamethasone, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9%sodium chlorideDrug
Also called placebo
unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
DexamethasoneDrug
unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
DexmedetomidineDrug
unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.2% ropivacaine for erector spinae plane block Receives: Drug: 0.9%sodium chloride |
| 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 (9)
Opioid consumption
Total opiate 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
NLR
Neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
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 posted31 Jan 2024
- Study start10 Apr 2024
- Primary completion30 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Triple blind
- Who is masked
- Participant, Care provider, 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
- Katarzyna Wieczorowska-Tobis, Prof.dr hab., Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233604
- Sponsor's protocol ID
- 2/2024
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2024
- Last updated
- 6 Nov 2026
- 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 6 Nov 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 Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06233604
- Acronym / sponsor ID
- 2/2024
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip 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
- 10 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 31 Jan 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 hip arthroplasty
Detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.
After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. 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 where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae 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
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9%sodium chloride0.2% 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 chlorideAlso: placebounilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block | Drug | Placebo |
| Dexamethasoneunilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block | Drug | Dexamethasone |
| Dexmedetomidineunilateral 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
9 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
NLR
Time frame: 48 hours after surgery
PLR
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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Katarzyna Wieczorowska-Tobis, Prof.dr hab. study chair
Poznań University of Medical Sciences
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, Dexamethasone and Dexmedetomidine in people with Hip Osteoarthritis and Hip Arthropathy, 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 6 Nov 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 6 Nov 2026.