AzTrials
AzTrials

Hip OstearthritisNCT07924709

Functional Recovery After PENG Block Plus Periarticular Injection Versus Periarticular Injection Alone in Total Hip Arthroplasty

A study testing Posterior Capsular Local Infiltration Analgesia and Ultrasound-Guided Pericapsular Nerve Group Block in people with Hip Ostearthritis, run by Poznan University of Medical Sciences at 2 sites in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Pain after hip replacement can make it difficult for older adults to get out of bed, stand up, and walk. This study will investigate whether adding a nerve block to pain-relieving injections given during surgery helps patients regain independence sooner. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Ostearthritis
What is being tested?
Posterior Capsular Local Infiltration Analgesia and Ultrasound-Guided Pericapsular Nerve Group Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
2 sitesPoland
Study dates
1 Dec 2026to 31 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65 years or older.
  • Scheduled for elective primary unilateral total hip arthroplasty for osteoarthritis through a posterior surgical approach.
  • Planned spinal anaesthesia and eligibility to receive either study analgesic strategy.
  • Ability to perform basic transfers and walk independently before surgery, with a walking aid permitted.
  • Ability to understand study instructions, report pain using the Numerical Rating Scale, and complete the study questionnaires.
  • Written informed consent provided before enrollment.

Who cannot join

  • Hip arthroplasty for an acute fracture, revision arthroplasty, or planned bilateral hip arthroplasty.
  • Pre-existing requirement for physical assistance from another person during basic transfers or walking.
  • Planned postoperative restrictions that prevent weight-bearing or participation in the study's functional assessments.
  • Neurological, neuromuscular, or other musculoskeletal disease that substantially limits mobility independently of the hip condition being treated.
  • Cognitive impairment or a communication disorder that prevents informed consent or reliable completion of study assessments.
  • Known hypersensitivity to ropivacaine or another medication required for the study interventions.
Show all 10Show fewer
  • Contraindication to spinal anaesthesia, PENG block, or posterior capsular infiltration, including local infection or a bleeding risk that cannot be managed in accordance with applicable regional anaesthesia guidelines.
  • A medical condition that makes the planned study interventions or early mobilization unsafe.
  • Planned use of an additional regional analgesic technique outside the study protocol.
  • Participation in another interventional study that could interfere with the assessment of pain or functional recovery.

Trial locations and contacts

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

Poland2 sites
  • Poznan University of Medical Sciences

    Poznan, 62-701

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

  • Poznan University of Medical Sciences

    Skórzewo, Poznań, 61-701

Other trials in Poland

About this study

Pain after hip replacement can make it difficult for older adults to get out of bed, stand up, and walk. This study will investigate whether adding a nerve block to pain-relieving injections given during surgery helps patients regain independence sooner.

The study will include adults aged 65 years or older undergoing planned first-time hip replacement for osteoarthritis. Participants will be assigned by chance to one of two groups. Both groups will receive an injection of a local anaesthetic, ropivacaine, into tissues around the back of the hip joint during surgery. One group will also receive an ultrasound-guided pericapsular nerve group (PENG) block, which involves injecting ropivacaine near nerves that carry pain signals from the hip. Both groups will receive the same usual pain treatment and rehabilitation programme.

Read more

The main assessment will take place 24 hours after surgery. A physiotherapist who does not know the participant's treatment group will assess how much help they need to get into and out of bed, stand up, walk, and use stairs.

The study will also assess pain, use of opioid pain medicines, muscle strength, quality of recovery, and side effects. The findings will help determine whether adding a PENG block provides a meaningful benefit for recovery after hip replacement.

Read the detailed description

This study addresses whether the analgesic effects of adding a pericapsular nerve group (PENG) block to posterior capsular local infiltration translate into better early functional recovery after total hip arthroplasty. Reduced pain or opioid consumption alone may not reflect a patient's ability to move independently, particularly when muscle weakness, dizziness, or sedation may also limit rehabilitation.

The primary assessment will therefore focus on the assistance required to perform everyday mobility tasks at a fixed postoperative time. This approach is intended to reduce the influence of staffing schedules and differences in the timing of the first mobilization attempt. Physiotherapists will receive standardized training in administering and scoring the functional assessment. Equivalent rehabilitation opportunities will be provided to both groups, including at weekends.

For each incomplete assessment, the reason will be documented to distinguish clinical inability to perform a task from an assessment missed for organizational reasons. Walking aids, assistance provided, and factors limiting performance will also be recorded.

The trial evaluates the additional value of a standard PENG block within an otherwise standardized care pathway. As the combined strategy includes a higher total dose of ropivacaine, any observed benefit will be interpreted as an effect of the overall strategy rather than proof of an effect attributable solely to the injection location.

Functional outcomes will be interpreted alongside analgesic requirements, muscle strength, patient-reported recovery, and adverse events to assess whether the additional procedure provides a meaningful overall benefit.

Being tested
Posterior Capsular Local Infiltration Analgesia, Ultrasound-Guided Pericapsular Nerve Group Block

What participants receive

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

  • Posterior Capsular Local Infiltration AnalgesiaDrug

    Intraoperative infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon during primary total hip arthroplasty. The infiltration technique and timing will be standardized according to the study protocol.

  • Ultrasound-Guided Pericapsular Nerve Group BlockDrug

    Ultrasound-guided single-injection pericapsular nerve group (PENG) block using 20 mL of 0.2% ropivacaine (40 mg). The block will be performed by an anaesthesiologist using a standardized technique according to the study protocol, in addition to posterior capsular local infiltration analgesia.

Study groups in NCT07924709
Study groupRoleWhat they receive
Posterior Capsular Local Infiltration Analgesia AloneActive comparatorParticipants will receive intraoperative local infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon. Participants will also receive standardized spinal anaesthesia, postoperative multimodal analgesia, rescue analgesia, and rehabilitation according to the study protocol.
Receives: Drug: Posterior Capsular Local Infiltration Analgesia
PENG Block Plus Posterior Capsular Local Infiltration AnalgesiaExperimentalParticipants will receive an ultrasound-guided pericapsular nerve group (PENG) block with 20 mL of 0.2% ropivacaine (40 mg), together with intraoperative local infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon. The total ropivacaine dose will be 80 mg. Participants will receive the same standardized spinal anaesthesia, postoperative multimodal analgesia, rescue analgesia, and rehabilitation as the comparator group.
Receives: Drug: Posterior Capsular Local Infiltration Analgesia; Drug: Ultrasound-Guided Pericapsular Nerve Group Block

What is being measured

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

  1. Modified Iowa Level of Assistance Scale Score at 24 Hours

    Functional recovery will be assessed using the five-item modified Iowa Level of Assistance Scale (mILAS). The scale evaluates the assistance required for supine-to-sitting transfer, sitting-to-supine transfer, sit-to-stand transfer, walking, and stair climbing. Each item is scored from 0 to 6, yielding a total score from 0 to 30. Lower scores indicate less assistance required and greater functional independence. A trained physiotherapist blinded to treatment allocation will administer the assessment according to a standardized scoring manual. The primary outcome is the total mILAS score at 24 hours after surgery.

    Measured: 24 hours after the end of surgery

Secondary outcomes (19)
  1. Modified Iowa Level of Assistance Scale Score at 48 Hours

    Functional recovery will be assessed using the five-item modified Iowa Level of Assistance Scale (mILAS). The scale evaluates the assistance required for supine-to-sitting transfer, sitting-to-supine transfer, sit-to-stand transfer, walking, and stair climbing. Each item is scored from 0 to 6, yielding a total score from 0 to 30. Lower scores indicate less assistance required and greater functional independence. A trained physiotherapist blinded to treatment allocation will administer the assessment according to a standardized scoring manual. The primary outcome is the total mILAS score at 48 hours after surgery.

    Measured: 48 hours after the end of surgery

  2. Quality of Recovery at 24 Hours

    Patient-reported recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better quality of recovery.

    Measured: 24 hours after the end of surgery

  3. Quality of Recovery at 48 Hours

    Patient-reported recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better quality of recovery.

    Measured: 48 hours after the end of surgery

  4. Pain Intensity at Rest

    Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately.

    Measured: 6 hours after the end of surgery

  5. Pain Intensity at Rest

    Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately.

    Measured: 12 hours after the end of surgery

  6. Pain Intensity at Rest

    Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately.

    Measured: 24 hours after the end of surgery

  7. Pain Intensity at Rest

    Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately.

    Measured: 48 hours after the end of surgery

  8. Pain Intensity During Movement

    Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately.

    Measured: 6 hours after the end of surgery

  9. Pain Intensity During Movement

    Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately.

    Measured: 12 hours after the end of surgery

  10. Pain Intensity During Movement

    Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately.

    Measured: 24 hours after the end of surgery

  11. Pain Intensity During Movement

    Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately.

    Measured: 48 hours after the end of surgery

  12. Cumulative Opioid Consumption During the First 24 Hours

    Cumulative dose of all opioid analgesics administered during the first 24 postoperative hours, converted to oral morphine milligram equivalents using conversion factors prespecified in the study protocol. Participants receiving no opioids will be assigned a value of zero.

    Measured: From the end of surgery through 24 hours after surgery

  13. Cumulative Opioid Consumption During the First 48 Hours

    Cumulative dose of all opioid analgesics administered during the first 48 postoperative hours, converted to oral morphine milligram equivalents using conversion factors prespecified in the study protocol. Participants receiving no opioids will be assigned a value of zero.

    Measured: From the end of surgery through 48 hours after surgery.

  14. Quadriceps Muscle Strength

    Quadriceps muscle strength of the operated limb will be assessed using the Medical Research Council (MRC) scale, ranging from 0 (no visible or palpable muscle contraction) to 5 (normal muscle strength). A trained physiotherapist blinded to treatment allocation will assess knee extension using standardized patient positioning and testing procedures. Higher scores indicate greater muscle strength. Scores at each assessment time will be analyzed separately.

    Measured: 24 hours after the end of surgery

  15. Quadriceps Muscle Strength

    Quadriceps muscle strength of the operated limb will be assessed using the Medical Research Council (MRC) scale, ranging from 0 (no visible or palpable muscle contraction) to 5 (normal muscle strength). A trained physiotherapist blinded to treatment allocation will assess knee extension using standardized patient positioning and testing procedures. Higher scores indicate greater muscle strength. Scores at each assessment time will be analyzed separately.

    Measured: 48 hours after the end of surgery

  16. Incidence of Postoperative Nausea and Vomiting

    Proportion of participants experiencing at least one episode of nausea or vomiting during the first 48 postoperative hours, regardless of whether antiemetic treatment is administered.

    Measured: 48 hours after surgery

  17. Symptomatic Orthostatic Intolerance During Mobilization

    Proportion of participants experiencing dizziness, lightheadedness, blurred vision, presyncope, or syncope during postoperative sitting, standing, or walking that requires the mobilization attempt to be interrupted or terminated.

    Measured: 48 hours after surgery.

  18. Postoperative Length of Hospital Stay

    Elapsed time in hours from the end of surgery to actual hospital discharge.

    Measured: From the end of surgery to hospital discharge.

  19. Incidence of Procedure-Related Adverse Events

    Proportion of participants experiencing at least one adverse event considered potentially related to the PENG block or posterior capsular infiltration, including local anaesthetic systemic toxicity, injection-site infection or hematoma, or new motor or sensory neurological deficit. Event type, onset, severity, duration, and assessed relationship to the intervention will be recorded.

    Measured: From administration of the study intervention through postoperative day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 Dec 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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07924709
Sponsor's protocol ID
22/2026
Status last verified
Nov 2026
First submitted
3 Nov 2026
Last updated
9 Nov 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 underlying the published study results will be available upon reasonable request. Shared data will include participant characteristics, allocated interventions, primary and secondary outcome data, and adverse events necessary to reproduce the reported analyses, together with a data dictionary. Direct identifiers will be removed, and potentially identifying variables will be modified or withheld to reduce the risk of re-identification. Data sharing will comply with participant consent, institutional requirements, and applicable data protection requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Posterior Capsular Local Infiltration Analgesia and Ultrasound-Guided Pericapsular Nerve Group Block in people with Hip Ostearthritis, run by Poznan University of Medical Sciences at 2 sites 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Iowa Level of Assistance Scale Score at 24 Hours (time frame: 24 hours after the end of 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 9 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in