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Hip OsteoarthritisNCT07330999

Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults

A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine in people with Hip Osteoarthritis, 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

This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Hip Osteoarthritis
What is being tested?
Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine
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
13 Feb 2026to 30 Sep 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
  • Planned use of a PENG block as part of perioperative analgesia
  • Ability to communicate pain intensity using the NRS scale
  • Written informed consent obtained from the patient or legal representative

Who cannot join

  • Refusal or inability to provide informed consent
  • Known allergy, intolerance, or contraindication to any of the study medications: ropivacaine, dexamethasone, dexmedetomidine
  • Pre-existing neurological deficit or neuropathy in the affected limb
  • Coagulopathy or laboratory abnormality that contraindicates regional anesthesia: INR >1.5, or platelet count <100,000/µL, or therapeutic anticoagulation that cannot be safely paused
  • Infection at or near the needle insertion site
  • Severe hepatic or renal impairment
Show all 12Show fewer
  • Chronic opioid therapy (>30 days of daily opioids before surgery)
  • Cognitive impairment or delirium that prevents reliable pain assessment
  • BMI >40 kg/m² (due to potential technical difficulty and reduced accuracy of ultrasound guidance)
  • Previous regional block affecting the target area for the current 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 Standard PENG Block Versus PENG With Perineural Dexamethasone or Perineural Dexmedetomidine in Patients Aged 65 Years and Older Undergoing Hip Surgery: A Randomized Controlled Trial

This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery.

All patients in the study will receive the PENG block using 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:

Read more

Group 1: PENG block using ropivacaine only (no additional medications). Group 2: PENG block using ropivacaine with 4 mg of dexamethasone injected near the nerves.

Group 3: PENG block using ropivacaine with 25 micrograms of dexmedetomidine injected near the nerves.

Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of regional anesthesia. It is not known whether adding one of these medications provides longer-lasting or better pain relief compared to using ropivacaine alone.

The main purpose of this study is to determine whether the addition of dexamethasone or dexmedetomidine improves the effectiveness of the PENG block in relieving pain after hip surgery. The study will evaluate pain levels, opioid consumption, time to first rescue pain medication, need for additional analgesia, and recovery outcomes. Safety, side effects, and any block-related complications will also be monitored.

The investigators hypothesize that adding either perineural dexamethasone or dexmedetomidine will result in longer and more effective pain relief compared with the standard PENG block without an adjuvant.

This research may help identify the most effective form of the PENG block for older adults undergoing hip surgery and contribute to improved pain management, reduced opioid use, and better postoperative recovery.

Read the detailed description

Hip surgery in older adults is frequently associated with significant postoperative pain, delayed mobilization, and increased opioid requirements. Poor pain control in this population can lead to complications such as delirium, prolonged hospitalization, reduced physical function, and slower rehabilitation. Effective regional anesthesia may improve safety and recovery after hip surgery.

The Pericapsular Nerve Group (PENG) block is a relatively new regional anesthesia technique designed to target the sensory innervation of the hip joint while preserving motor function. This motor-sparing feature may allow earlier mobilization and reduce the negative effects of immobilization in older patients.

Ropivacaine is the standard local anesthetic commonly used in peripheral nerve blocks. Small doses of adjuvant medications such as dexamethasone or dexmedetomidine may prolong the duration of analgesia and improve the quality of pain control. However, it remains unclear whether the addition of these medications provides any clinically meaningful benefit when used with the PENG block in older adults. There is also limited evidence directly comparing different adjuvants to a standard PENG block without additional medication.

This randomized controlled trial will compare three variants of the PENG block in adults aged 65 years and older undergoing hip surgery. All participants will receive a PENG block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:

Standard PENG block with ropivacaine alone (no adjuvant). PENG block with 4 mg of perineural dexamethasone. PENG block with 25 micrograms of perineural dexmedetomidine. All patients will receive standard perioperative care and multimodal analgesia. The study will assess pain scores, time to first rescue analgesia, total opioid consumption, functional mobility, incidence of postoperative nausea and vomiting, block duration, motor function, and complications. Safety will also be monitored, including block-related and neurological adverse events.

The primary objective of this study is to determine whether perineural dexamethasone or dexmedetomidine improves postoperative analgesia compared with a standard PENG block without adjuvant. The investigators hypothesize that both adjuvants may prolong analgesia and reduce opioid requirements, but their effectiveness and safety profile may differ.

This study aims to provide evidence that can help guide anesthesiologists in selecting the optimal variant of the PENG block for older adults undergoing hip surgery, intending to improve postoperative pain control, support early rehabilitation, and reducing complications associated with opioid use and delayed mobilization.

Being tested
Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg, Dexmedetomidine
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

    20 mL of 0.2% ropivacaine administered perineurally as part of the PENG block. No perineural or intravenous adjuvant drugs will be used in this arm.

  • Dexamethasone 4mgDrug

    4 mg of dexamethasone administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.

  • DexmedetomidineDrug

    25 micrograms of dexmedetomidine administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.

Study groups in NCT07330999
Study groupRoleWhat they receive
PENG Block With Ropivacaine Only (Control)Active comparatorParticipants will receive a Pericapsular Nerve Group (PENG) block using 20 mL of 0.2% ropivacaine without any adjuvant administered perineurally or intravenously. All participants will receive standard perioperative care and multimodal analgesia. Ondansetron will be used as standard prophylaxis for postoperative nausea and vomiting.
Receives: Drug: Ropivacaine 0.2% Injectable Solution
PENG Block With Perineural DexamethasoneActive comparatorParticipants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 4 mg of dexamethasone administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
Receives: Drug: Dexamethasone 4mg
PENG Block With Perineural DexmedetomidineActive comparatorParticipants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
Receives: Drug: Dexmedetomidine

What is being measured

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

  1. Time to First Rescue Analgesia

    Time (in hours) from completion of the PENG block to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).

    Measured: Within 48 hours after surgery.

Secondary outcomes (19)
  1. Pain Intensity at Rest (NRS 0-10)

    Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

    Measured: 4 hours after surgery.

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

    ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

    Measured: 8 hours after surgery.

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

    ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

    Measured: 12 hours after surgery.

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

    ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

    Measured: 24 hours after surgery.

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

    ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

    Measured: 48 hours after surgery.

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

    Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.

    Measured: 4 hours after surgery.

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

    Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.

    Measured: 8 hours after surgery.

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

    Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.

    Measured: 12 hours after surgery.

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

    Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.

    Measured: 24 hours after surgery.

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

    Pain intensity during standardized hip movement (e.g., flexion or assisted mobilization) measured using the 0-10 Numerical Rating Scale.

    Measured: 48 hours after surgery.

  11. Total Opioid Consumption

    Cumulative dose of opioids converted to oral morphine milligram equivalents (MME).

    Measured: 0-24 hours and 0-48 hours after surgery.

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

    Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.

    Measured: 4 hours after surgery.

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

    Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.

    Measured: 8 hours after surgery.

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

    Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.

    Measured: 12 hours after surgery.

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

    Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.

    Measured: 24 hours after surgery.

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

    Quadriceps muscle strength will be assessed using the Medical Research Council (MRC) scale (0 = no contraction; 5 = normal power) to detect any motor impairment associated with the applied regional anesthesia techniques.

    Measured: 48 hours after surgery.

  17. Incidence of Postoperative Nausea and Vomiting (PONV)

    Presence of nausea or vomiting requiring antiemetic therapy. Proportion of patients with at least one episode will be recorded.

    Measured: 0-48 hours after surgery.

  18. Hemodynamic Adverse Events

    Incidence of hypotension (systolic BP <90 mmHg or >30% decrease from baseline) and bradycardia (HR <50/min) requiring treatment.

    Measured: From block placement until 24 hours after surgery.

  19. Block-Related Adverse Events, Including Neurological Complications

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

    Measured: From block placement until 30 days 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 posted9 Jan 2026
  2. Study start13 Feb 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion30 Sep 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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07330999
Sponsor's protocol ID
10/2025
Status last verified
Nov 2026
First submitted
28 Dec 2025
Last updated
5 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 (IPD) that support the results of this study will be made available to other researchers. Shared IPD will include demographic information, clinical outcomes, adverse events, and all primary and secondary outcome variables collected during the study. No information that could identify participants will be included.

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine in people with 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 6 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 5 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 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?

Time to First Rescue Analgesia (time frame: Within 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 5 Nov 2026.

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