Hip ArthropathyPhase 4NCT07023120

PENG Block Optimization: Volume and Dexamethasone Effects

A Phase 4 study testing Ropivacaine 0.2% Injectable Solution and Dexamethasone 4mg in people with Hip Arthropathy and Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 100 years
Conditions the study is for: Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis
What is being tested?: Ropivacaine 0.2% Injectable Solution and Dexamethasone 4mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 sitePoland
Study dates: 25 Jun 2025to 20 Feb 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 60 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).
American Society of Anesthesiologists (ASA) physical status I-III.
Ability to provide written informed consent.
Spinal anesthesia planned as the primary anesthetic technique.
Body mass index (BMI) between 18 and 35 kg/m².
Fluent in the local language and able to understand the NRS pain scoring system.

Who cannot join

Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.
Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.
Chronic opioid use (daily use >30 mg oral morphine equivalents for >1 month prior to surgery).
History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.
Uncontrolled diabetes mellitus (HbA1c > 9%) or active systemic infection.
Pregnancy or breastfeeding.
Previous surgery or implantation on the ipsilateral hip.
Inability to cooperate with postoperative assessments or participate in follow-up.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Poznan University of Medical Sciences
Poznan

Other trials in Poland

About this study

Official title: Optimizing PENG Block in Hip Arthroplasty: Influence of Ropivacaine Volume and Dexamethasone on Analgesic Efficacy

This randomized controlled trial investigates the impact of local anesthetic volume and perineural dexamethasone on the analgesic and anti-inflammatory effectiveness of the pericapsular nerve group (PENG) block in patients undergoing total hip arthroplasty (THA). Patients were randomized to receive one of four PENG block variants differing in ropivacaine volume (10 mL or 20 mL of 0.2%) and the addition of 4 mg of perineural dexamethasone. The study evaluates postoperative pain, opioid requirements, systemic inflammatory markers, and quadriceps motor preservation.

Read the detailed description

The pericapsular nerve group (PENG) block has become a widely used motor-sparing component of multimodal analgesia for total hip arthroplasty (THA). However, its optimal formulation-particularly the volume of local anesthetic and the role of adjuvants-remains undetermined. This prospective, double-blind, randomized controlled trial evaluates the influence of ropivacaine volume (10 mL vs. 20 mL of 0.2%) and the addition of perineural dexamethasone (4 mg) on analgesic efficacy, opioid consumption, systemic inflammation, and quadriceps strength preservation.

A total of 120 adult patients undergoing unilateral THA under spinal anesthesia were randomized to one of four PENG block groups:

Group 1: 20 mL of 0.2% ropivacaine (standard-volume PENG) Group 2: 20 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone Group 3: 10 mL of 0.2% ropivacaine (low-volume PENG) Group 4: 10 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone The primary outcome was the time to first rescue opioid analgesia. Secondary outcomes included total 48-hour opioid consumption (expressed in oral morphine equivalents), numeric rating scale (NRS) pain scores, quadriceps muscle strength, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) at 12, 24, and 48 hours postoperatively.

Results demonstrated that the addition of dexamethasone, regardless of volume, significantly prolonged the duration of analgesia and reduced opioid consumption compared to non-adjuvanted PENG blocks. The low-volume + dexamethasone group achieved comparable analgesia to high-volume protocols with better inflammatory profiles. Quadriceps strength was preserved in all groups. These findings support the use of perineural dexamethasone as an effective enhancer of PENG block analgesia while enabling lower local anesthetic volume, potentially improving safety and recovery outcomes in THA patients.

Conditions: Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis
Being tested: Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg
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
Dexamethasone 4mgDrug
perineural 4mg Dexamethasone
Ropivacaine 0.2% Injectable SolutionDrug
10ml 0.2% Ropivacaine

Study groups in NCT07023120
Study group	Role	What they receive
PENG 20 mL	Active comparator	Ultrasound-guided PENG block - 20ml 0,2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution
PENG 20 mL + DEX	Active comparator	Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone Receives: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Dexamethasone 4mg
PENG 10 mL	Active comparator	Ultrasound-guided PENG block - 10ml 0,2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution
PENG 10 mL + DEX	Active comparator	Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone Receives: Drug: Dexamethasone 4mg; Drug: Ropivacaine 0.2% Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to first rescue opioid
Time after surgery when the patient needs opiate for the first time
Measured: 24 hours after surgery

Secondary outcomes (23)

Total 48h 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
NLR
neutrophile-to-lymphocyte ratio
Measured: 12 hours after surgery
NLR
neutrophile-to-lymphocyte ratio
Measured: 24 hours after surgery
NLR
neutrophile-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
platelet-to-lymphocyte ratio
Measured: 12 hours after surgery
PLR
platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
PLR
platelet-to-lymphocyte ratio
Measured: 48 hours after surgery
Quadriceps strength
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 strength
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 strength
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 strength
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 strength
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
blood glucose
blood glucose level
Measured: 12 hours after surgery
blood glucose
blood glucose level
Measured: 24 hours after surgery
blood glucose
blood glucose level
Measured: 48 hours after surgery
Nerve damage
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
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
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.

25 Jun 202520 Feb 2026

First posted15 Jun 2025
Study start25 Jun 2025
Primary completion10 Feb 2026
Study completion20 Feb 2026

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07023120
Sponsor's protocol ID: 8/2025
Status last verified: Jun 2025
First submitted: 8 Jun 2025
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

All Hip Arthropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing PENG Block in Hip Arthroplasty: Influence of Ropivacaine Volume and Dexamethasone on Analgesic Efficacy
ClinicalTrials.gov ID: NCT07023120
Acronym / sponsor ID: 8/2025
Conditions: Hip Arthropathy, Hip Osteoarthritis, Hip Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Poznan University of Medical SciencesUniversity, hospital or other
Study start: 25 Jun 2025 (actual)
Primary completion: 10 Feb 2026 (actual)
Study completion: 20 Feb 2026 (actual)
First posted: 15 Jun 2025 (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.

Detailed description

A total of 120 adult patients undergoing unilateral THA under spinal anesthesia were randomized to one of four PENG block groups:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
PENG 20 mL	Active comparator	Drug: Ropivacaine 0.2% Injectable SolutionUltrasound-guided PENG block - 20ml 0,2% ropivacaine
PENG 20 mL + DEX	Active comparator	Drug: Ropivacaine 0.2% Injectable Solution, Drug: Dexamethasone 4mgUltrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone
PENG 10 mL	Active comparator	Drug: Ropivacaine 0.2% Injectable SolutionUltrasound-guided PENG block - 10ml 0,2% ropivacaine
PENG 10 mL + DEX	Active comparator	Drug: Dexamethasone 4mg, Drug: Ropivacaine 0.2% Injectable SolutionUltrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone

Who may qualify

Ages: 60 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).
American Society of Anesthesiologists (ASA) physical status I-III.
Ability to provide written informed consent.
Spinal anesthesia planned as the primary anesthetic technique.
Body mass index (BMI) between 18 and 35 kg/m².

Key exclusion criteria (8 listed)

Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.
Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.
Chronic opioid use (daily use >30 mg oral morphine equivalents for >1 month prior to surgery).
History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.
Uncontrolled diabetes mellitus (HbA1c > 9%) or active systemic 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 0.2% Injectable Solution20ml 0.2% Ropivacaine	Drug	PENG 20 mL, PENG 20 mL + DEX
Dexamethasone 4mgperineural 4mg Dexamethasone	Drug	PENG 10 mL + DEX, PENG 20 mL + DEX
Ropivacaine 0.2% Injectable Solution10ml 0.2% Ropivacaine	Drug	PENG 10 mL, PENG 10 mL + DEX

Primary outcome

Time to first rescue opioid
Time frame: 24 hours after surgery
Time after surgery when the patient needs opiate for the first time

23 secondary outcomes

Total 48h 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
NLR
Time frame: 12 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
Time frame: 48 hours after surgery
Quadriceps strength
Time frame: 4 hours after surgery
Quadriceps strength
Time frame: 8 hours after surgery
Quadriceps strength
Time frame: 12 hours after surgery
Quadriceps strength
Time frame: 24 hours after surgery
Quadriceps strength
Time frame: 48 hours after surgery
blood glucose
Time frame: 12 hours after surgery
blood glucose
Time frame: 24 hours after surgery
blood glucose
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

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 16 Mar 2026.

Related trials for Hip Arthropathy

Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

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 Reysner, M.D. Ph.D. study chair

Poznan 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?

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 6 inclusion and 8 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 16 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. 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 (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07023120.

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 16 Mar 2026.