Hip OsteoarthritisPhase 4NCT06470139
Dexamethasone for PENG Block in Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone in people with Hip Osteoarthritis and Hip Arthropathy, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- What is being tested?
- Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 13 Aug 2024to 10 Feb 2025
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients scheduled for total hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Who cannot join
- inability to provide first-party consent due to cognitive impairment or a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group (PENG) Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Hip Arthroplasty: a Randomized Controlled Trial
Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty
Read the detailed description
Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- Being tested
- Ropivacaine 0.2% Injectable Solution, Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl
Ropivacaine 0.2% Injectable Solution + 4mg DexamethasoneDrug
20ml 0.2% Ropivacaine + 4mg Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Ropivacaine+Dexamethasone | Active comparator | Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone Receives: Drug: Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after surgery
Secondary outcomes (17)
Total Opioid Consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 48 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 12 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 24 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 48 hours after surgery
glucose
blood glucose levels
Measured: 24 hours after surgery
glucose
blood glucose levels
Measured: 12 hours after surgery
glucose
blood glucose levels
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 completion15 Jan 2025
- Study completion10 Feb 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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. Ph.D., Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470139
- Sponsor's protocol ID
- 6/2024
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06470139
- Acronym / sponsor ID
- 6/2024
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 10 Feb 2025 (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 adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty
Detailed description
Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionUltrasound-guided PENG block - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl |
| Ropivacaine+Dexamethasone | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution + 4mg DexamethasoneUltrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients scheduled for total hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Key exclusion criteria (1 listed)
- inability to provide first-party consent due to cognitive impairment or a language barrier
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable Solution20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl | Drug | Ropivacaine |
| Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone20ml 0.2% Ropivacaine + 4mg Dexamethasone | Drug | Ropivacaine+Dexamethasone |
Primary outcome
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Time after surgery when the patient needs opiate for the first time
17 secondary outcomes
Total 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: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 48 hours after surgery
Nerve damage
Time frame: 12 hours after surgery
Nerve damage
Time frame: 24 hours after surgery
Nerve damage
Time frame: 48 hours after surgery
glucose
Time frame: 24 hours after surgery
glucose
Time frame: 12 hours after surgery
glucose
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 24 Mar 2025.
- Individual participant dataSharing planned: Yes
Related trials for 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
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
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
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.
Malgorzata Domagalska, M.D. Ph.D. 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 Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone 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 4 inclusion and 1 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 24 Mar 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 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. 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?
Time to first rescue opioid analgesia (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 24 Mar 2025.