Hip ArthropathyPhase 4NCT06083428
Erector Spinae vs. PENG Block for Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block and Ropivacaine 0.2% Injectable Solution - PENG block in people with Hip Arthropathy and Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of PENG block and ESPB on pain management, and NLR and PLR following knee arthroplasty Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hip Arthropathy, Hip Osteoarthritis, Hip Pain Chronic
- What is being tested?
- Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block and Ropivacaine 0.2% Injectable Solution - PENG block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 17 Oct 2023to 11 Jun 2024
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia.
Who cannot join
- Patients who have a history of bleeding diathesis, Take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block (ESPB) vs. PENG Block for Pain Management and Stress Response in Patients Undergoing Total Hip Arthroplasty. A Prospective, Randomized Trial.
Effect of PENG block and ESPB on pain management, and NLR and PLR following knee arthroplasty
Read the detailed description
Hip arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.
This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing hip replacement surgery.
- Conditions
- Hip Arthropathy, Hip Osteoarthritis, Hip Pain Chronic
- Being tested
- Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block, Ropivacaine 0.2% Injectable Solution - PENG block, Control Test
- 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 Solution Erector Spinae Plane BlockDrug
Also called Erector Spinae Plane Block
ultrasound guided ESPB - L4 level, unilateral
Ropivacaine 0.2% Injectable Solution - PENG blockDrug
Also called PENG block
ultrasound guided PENG block
Control TestDrug
Also called No peripheral nerve block
Only spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| PENG Block group | Active comparator | ultrasound guided PENG block - 20ml 0,2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution - PENG block |
| ESPB group | Active comparator | ultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Block |
| Control group | Active comparator | Only spinal anesthesia - No peripheral nerve block Receives: Drug: Control Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Secondary outcomes (13)
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after procedure
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: 18 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: 36 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
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 24 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
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: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start17 Oct 2023
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- Małgorzata Domagalska, Ph.D., Principal investigator, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083428
- Sponsor's protocol ID
- 11/2023
- Status last verified
- Jun 2024
- First submitted
- 24 May 2023
- Last updated
- 18 Jun 2024
- 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block (ESPB) vs. PENG Block for Pain Management and Stress Response in Patients Undergoing Total Hip Arthroplasty. A Prospective, Randomized Trial.
- ClinicalTrials.gov ID
- NCT06083428
- Acronym / sponsor ID
- 11/2023
- Conditions
- Hip Arthropathy, Hip Osteoarthritis, 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
- 17 Oct 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 16 Oct 2023 (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 PENG block and ESPB on pain management, and NLR and PLR following knee arthroplasty
Detailed description
Hip arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.
This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing hip replacement surgery.
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 |
|---|---|---|
| PENG Block group | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution - PENG blockultrasound guided PENG block - 20ml 0,2% ropivacaine |
| ESPB group | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution Erector Spinae Plane Blockultrasound guided erector spinae plane block - 20ml 0,2% ropivacaine |
| Control group | Active comparator | Drug: Control TestOnly spinal anesthesia - No peripheral nerve block |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for hip arthroplasty under spinal anesthesia.
Key exclusion criteria (1 listed)
- Patients who have a history of bleeding diathesis, Take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure
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 Solution Erector Spinae Plane BlockAlso: Erector Spinae Plane Blockultrasound guided ESPB - L4 level, unilateral | Drug | ESPB group |
| Ropivacaine 0.2% Injectable Solution - PENG blockAlso: PENG blockultrasound guided PENG block | Drug | PENG Block group |
| Control TestAlso: No peripheral nerve blockOnly spinal anesthesia | Drug | Control group |
Primary outcome
Opioid consumption
Time frame: 48 hours after surgery
Total opiate consumption after surgery
13 secondary outcomes
first need of opiate
Time frame: 48 hours after procedure
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: 18 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
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 48 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: Postoperative 24 hours period
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 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Hip Arthropathy
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
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Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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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.
Małgorzata Domagalska, Ph.D. principal investigator
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 Erector Spinae Plane Block and Ropivacaine 0.2% Injectable Solution - PENG block in people with Hip Arthropathy and Hip Osteoarthritis, 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 1 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 18 Jun 2024. 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?
Opioid consumption (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 18 Jun 2024.