Hip OsteoarthritisPhase 4NCT05944380
PENG Block for Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine 0.5% Injectable Solution and 0,9% normal saline in people with Hip Osteoarthritis and Hip Arthropathy, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Hip Disease
- What is being tested?
- Ropivacaine 0.5% Injectable Solution and 0,9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jun 2020to 30 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years old undergoing unilateral total hip arthroplasty
Who cannot join
- refusal to participate
- < 18 yo
- Chronic opioid use
- localized infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.
Read the detailed description
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Disease, Hip Pain Chronic
- Being tested
- Ropivacaine 0.5% Injectable Solution, 0,9% normal saline
- Keywords
- periarticular nerve group block, total hip arthroplasty, pain management, multimodal analgesia, regional anesthesia
- Medical subject headings
- Osteoarthritis, Hip, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Also called Ropimol
20 mL 0.5% ropivacaine will be injected for the PENG block
0,9% normal salineDrug
Also called placebo
20 mL 0.9% normal saline will be injected for the PENG block
| Study group | Role | What they receive |
|---|---|---|
| PENG with 20mL 0,5% Ropivacaine | Experimental | Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| PENG block with 20mL 0,9% normal saline | Experimental | Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. Receives: Drug: 0,9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative Numeric Pain Rating Scale in motion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 2
postoperative Numeric Pain Rating Scale in motion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 3
postoperative Numeric Pain Rating Scale in motion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 4
Secondary outcomes (10)
total opioid consumption
milligrams of intravenous morphine equivalents
Measured: 96 hours postoperatively
Time to first opioid
Hours to first administration of an intravenous opioid drug
Measured: 96 hours postoperatively
postoperative Numeric Pain Rating Scale et rest
representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 1
postoperative Numeric Pain Rating Scale et rest
representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 2
postoperative Numeric Pain Rating Scale et rest
representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 3
postoperative Numeric Pain Rating Scale et rest
representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Day 4
Functional assessment: getting out of bed without help
Binary assessment of motor function evaluated at the first day after surgical procedure
Measured: First day after surgery
Functional assessment: active elevation of the operated limb
Binary assessment of motor function evaluated at the first day after surgical procedure
Measured: First day after surgery
Functional assessment: independent verticalization- by the balcony
Binary assessment of motor function evaluated at the first day after surgical procedure
Measured: First day after surgery
Functional assessment: walking by the balcony
Binary assessment of motor function evaluated at the first day after surgical procedure
Measured: First day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start16 Jun 2020
- Primary completion23 Jun 2022
- Study completion30 Jan 2023
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
- Model description
- randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Domagalska, PhD, Principal investigator, Department of Palliative Medicine, University of Medical Sciences, Poznań, PolandZbigniew Żaba, PhD, Study chair, Department of Emergency Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944380
- Sponsor's protocol ID
- 496/20
- Status last verified
- Jul 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05944380
- Acronym / sponsor ID
- 496/20
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Disease, Hip Pain Chronic
- Keywords
- periarticular nerve group block, total hip arthroplasty, pain management, multimodal analgesia, regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Jul 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.
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.
Detailed description
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| PENG with 20mL 0,5% Ropivacaine | Experimental | Drug: Ropivacaine 0.5% Injectable SolutionPatients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. |
| PENG block with 20mL 0,9% normal saline | Experimental | Drug: 0,9% normal salinePatients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years old undergoing unilateral total hip arthroplasty
Key exclusion criteria (4 listed)
- refusal to participate
- < 18 yo
- Chronic opioid use
- localized infection
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 0.5% Injectable SolutionAlso: Ropimol20 mL 0.5% ropivacaine will be injected for the PENG block | Drug | PENG with 20mL 0,5% Ropivacaine |
| 0,9% normal salineAlso: placebo20 mL 0.9% normal saline will be injected for the PENG block | Drug | PENG block with 20mL 0,9% normal saline |
Primary outcome
postoperative Numeric Pain Rating Scale in motion
Time frame: Day 2
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale in motion
Time frame: Day 3
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale in motion
Time frame: Day 4
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
10 secondary outcomes
total opioid consumption
Time frame: 96 hours postoperatively
Time to first opioid
Time frame: 96 hours postoperatively
postoperative Numeric Pain Rating Scale et rest
Time frame: Day 1
postoperative Numeric Pain Rating Scale et rest
Time frame: Day 2
postoperative Numeric Pain Rating Scale et rest
Time frame: Day 3
postoperative Numeric Pain Rating Scale et rest
Time frame: Day 4
Functional assessment: getting out of bed without help
Time frame: First day after surgery
Functional assessment: active elevation of the operated limb
Time frame: First day after surgery
Functional assessment: independent verticalization- by the balcony
Time frame: First day after surgery
Functional assessment: walking by the balcony
Time frame: First day 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 13 Jul 2023.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on request from the corresponding author.
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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, PhD principal investigator
Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
Zbigniew Żaba, PhD study chair
Department of Emergency Medicine Clinic
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 0.5% Injectable Solution and 0,9% normal saline 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 1 inclusion and 4 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 13 Jul 2023. 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?
postoperative Numeric Pain Rating Scale in motion (time frame: Day 2). The study lists 3 primary outcomes in all. 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 13 Jul 2023.