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Hip OsteoarthritisNCT07327892

PENG Block vs PENG Plus Periarticular Injection vs Periarticular Injection in Older Adults

A study testing Pericapsular Nerve Group (PENG) Block and Periarticular Injection (PAI) in people with Hip Osteoarthritis and Arthropathy of Hip, run by Poznan University of Medical Sciences at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Pain after hip surgery is common in older adults and may limit early mobilization, increase the need for opioid medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Hip Osteoarthritis, Arthropathy of Hip
What is being tested?
Pericapsular Nerve Group (PENG) Block and Periarticular Injection (PAI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 sitePoland
Study dates
8 May 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age 65 years or older
  • Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
  • ASA physical status I-III
  • Ability to communicate pain intensity using the NRS scale
  • Written informed consent obtained from the patient or legal representative

Who cannot join

  • Patient refusal or inability to provide informed consent
  • Allergy, intolerance, or contraindication to any study medication: ropivacaine
  • Pre-existing neurological deficit or neuropathy of the affected limb
  • Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
  • Infection at or near the injection site
  • Severe hepatic or renal impairment
Show all 12Show fewer
  • History of chronic opioid use (daily opioids >30 days before surgery)
  • Cognitive impairment or delirium precluding reliable pain assessment
  • BMI > 40 kg/m² (if you want to exclude for technical difficulty)
  • Patients receiving another regional nerve block for hip surgery
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 30 days

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malgorzata Reysner, MD PhD contact

+48 61 873 83 03

mreysner@ump.edu.pl

Poland1 site, 1 recruiting
  • Poznan University of Medical Sciences

    Poznan, 62-701

    Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Comparison of Pericapsular Nerve Group (PENG) Block, PENG Block Plus Periarticular Injection, and Periarticular Injection Alone for Postoperative Pain Management in Older Adults Undergoing Hip Surgery: A Randomized Controlled Trial

Pain after hip surgery is common in older adults and may limit early mobilization, increase the need for opioid medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Effective postoperative pain management that preserves muscle strength and supports early rehabilitation is especially important in this population.

Several analgesic strategies are currently used after hip surgery. Periarticular injection (PAI), administered by the surgeon during the procedure, is commonly used as part of standard care. The pericapsular nerve group (PENG) block is a newer ultrasound-guided regional anesthesia technique that targets the sensory nerves of the hip joint while sparing motor function. It may provide effective pain relief and facilitate early mobilization. However, it is unclear whether PENG block alone is superior to periarticular injection, and whether combining both techniques provides additional benefit.

Read more

The aim of this randomized controlled clinical study is to compare three postoperative analgesic strategies in older adults undergoing hip surgery: PENG block alone, PENG block combined with periarticular injection, and periarticular injection alone. Participants will be randomly assigned to one of three study groups.

The primary hypothesis is that regional anesthesia with a PENG block, either alone or combined with periarticular injection, will provide superior postoperative pain control compared with periarticular injection alone. A secondary hypothesis is that the combination of PENG block and periarticular injection will offer additional analgesic benefit compared with PENG block alone.

Outcomes assessed in this study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of adverse events relevant to older adults, such as hypotension, excessive sedation, or postoperative delirium.

The results of this study may help determine the most effective and practical analgesic strategy for hip surgery in older adults and support evidence-based optimization of postoperative pain management.

Read the detailed description

Postoperative pain following hip surgery is a major clinical challenge in older adults and is associated with delayed mobilization, increased opioid consumption, higher risk of delirium, and prolonged hospitalization. Analgesic strategies that provide effective pain relief while preserving motor function are particularly important to support early rehabilitation and reduce postoperative complications in this vulnerable population.

Periarticular injection (PAI), administered intraoperatively by the surgeon, is widely used as part of multimodal analgesia after hip surgery and is considered standard practice in many institutions. The pericapsular nerve group (PENG) block is a relatively new ultrasound-guided regional anesthesia technique designed to selectively block the sensory innervation of the anterior hip capsule while sparing motor nerves. Early clinical data suggest that the PENG block may improve postoperative analgesia and facilitate early mobilization; however, its comparative effectiveness relative to periarticular injection, as well as the potential benefit of combining both techniques, remains insufficiently studied.

This study is designed as a prospective, randomized, controlled, three-arm clinical trial comparing different postoperative analgesic strategies in older adults undergoing hip surgery. Eligible participants will be randomly assigned to one of three groups:

  1. PENG block alone,
  2. PENG block combined with periarticular injection, or
  3. periarticular injection alone. The PENG block will be performed under ultrasound guidance by an experienced anesthesiologist prior to surgery using a standardized technique. Periarticular injection will be administered intraoperatively by the operating surgeon according to a standardized institutional protocol. Apart from the assigned analgesic strategy, all participants will receive standardized anesthesia and postoperative multimodal pain management to minimize confounding factors.

The primary objective of the study is to compare the effectiveness of these three analgesic strategies in controlling postoperative pain after hip surgery in older adults. Secondary objectives include assessment of opioid consumption, time to first mobilization, functional recovery, and patient comfort. Safety outcomes will also be evaluated, with particular attention to adverse events relevant to older adults, including hypotension, bradycardia, excessive sedation, nausea, vomiting, and postoperative delirium.

The results of this study are expected to provide clinically meaningful evidence on whether the PENG block offers advantages over standard periarticular injection and whether combining both techniques yields additional benefit. These findings may inform clinical decision-making and contribute to the optimization of postoperative pain management strategies for older adults undergoing hip surgery.

Being tested
Pericapsular Nerve Group (PENG) Block, Periarticular Injection (PAI)
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pericapsular Nerve Group (PENG) BlockProcedure or surgery

    Also called Ultrasound-guided PENG block

    Ultrasound-guided regional anesthesia technique targeting sensory innervation of the anterior hip capsule, performed as a single injection prior to surgery using a standardized protocol.

  • Periarticular Injection (PAI)Procedure or surgery

    Also called Local infiltration analgesia; periarticular local anesthetic injection

    Intraoperative periarticular injection performed by the surgeon according to a standardized institutional protocol as part of postoperative pain management.

Study groups in NCT07327892
Study groupRoleWhat they receive
PENG BlockActive comparatorParticipants will receive an ultrasound-guided pericapsular nerve group (PENG) block administered as a single perineural injection prior to surgery, using a standardized technique.
Receives: Procedure: Pericapsular Nerve Group (PENG) Block
PENG Block Plus Periarticular Injection (PAI)ExperimentalParticipants will receive an ultrasound-guided PENG block (single perineural injection prior to surgery) plus a periarticular injection administered intraoperatively by the surgeon according to a standardized protocol.
Receives: Procedure: Pericapsular Nerve Group (PENG) Block; Procedure: Periarticular Injection (PAI)
Periarticular Injection (PAI) AloneActive comparatorParticipants will receive a periarticular injection administered intraoperatively by the surgeon according to a standardized protocol, without a PENG block.
Receives: Procedure: Periarticular Injection (PAI)

What is being measured

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

  1. otal Opioid Consumption

    Cumulative dose of all opioid analgesics administered in the postoperative period, converted to oral morphine milligram equivalents (MME). Values at 24 and 48 hours will be recorded and compared between groups.

    Measured: 0-48 hours after surgery

Secondary outcomes (18)
  1. Time to First Rescue Analgesia

    Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.

    Measured: Within 48 hours after the end of surgery

  2. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.

    Measured: 4 hours after surgery

  3. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.

    Measured: 8 hours after surgery

  4. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.

    Measured: 12 hours after surgery

  5. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.

    Measured: 24 hours after surgery

  6. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.

    Measured: 48 hours after surgery

  7. Pain Intensity During Movement (NRS 0-10)

    Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.

    Measured: 4 hours after surgery

  8. Pain Intensity During Movement (NRS 0-10)

    Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.

    Measured: 8 hours after surgery

  9. Pain Intensity During Movement (NRS 0-10)

    Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.

    Measured: 12 hours after surgery

  10. Pain Intensity During Movement (NRS 0-10)

    Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.

    Measured: 24 hours after surgery

  11. Pain Intensity During Movement (NRS 0-10)

    Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.

    Measured: 48 hours after surgery

  12. Incidence of Postoperative Nausea and Vomiting (PONV)

    Presence of nausea and/or vomiting requiring antiemetic therapy. The proportion of patients with at least one episode of PONV will be recorded and compared between groups

    Measured: 0-48 hours after surgery

  13. Block-Related Adverse Events, Including Neurological Complications

    Incidence of complications potentially related to the PENG block or perineural adjuvants, including signs of local anesthetic systemic toxicity, prolonged motor or sensory deficit, nerve injury (evaluated in the postoperative clinic or outpatient nerve injury clinic if required), infection at the injection site, hematoma, or persistent weakness.

    Measured: From block placement until hospital discharge, up to 30 days

  14. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia

    Measured: 4 hours after surgery

  15. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia

    Measured: 8 hours after surgery

  16. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia

    Measured: 12 hours after surgery

  17. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia

    Measured: 24 hours after surgery

  18. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia

    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.

  1. First posted8 Jan 2026
  2. Study start8 May 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327892
Sponsor's protocol ID
17/2025
Status last verified
Dec 2025
First submitted
28 Dec 2025
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. Shared data will include baseline characteristics, outcome measures, and safety data necessary to reproduce the main analyses. All data will be fully anonymized prior to sharing to protect participant privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Pericapsular Nerve Group (PENG) Block and Periarticular Injection (PAI) in people with Hip Osteoarthritis and Arthropathy of Hip, 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 5 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: looking for participants now, as of the sponsor's last update on 1 Jul 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Malgorzata Reysner, MD PhD (+48 61 873 83 03, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

otal Opioid Consumption (time frame: 0-48 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 1 Jul 2026.

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