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Hip OsteoarthritisNCT07327931

PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

A study testing Dexamethasone (intravenous), Dexamethasone (intravenous) with Dexmedetomidine (perineural) and Dexamethasone (perineural) with Dexmedetomidine (perineural) in people with Hip Osteoarthritis and Hip Pain Chronic, 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 different versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing surgery for hip conditions. The PENG block is a regional anesthesia technique that can reduce pain after surgery and decrease the need for strong opioid pain medications. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Hip Osteoarthritis, Hip Pain Chronic
What is being tested?
Dexamethasone (intravenous), Dexamethasone (intravenous) with Dexmedetomidine (perineural) and Dexamethasone (perineural) with Dexmedetomidine (perineural)
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 31 Jan 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
  • Planned use of PENG block as part of multimodal perioperative analgesia

Who cannot join

  • Patient refusal or inability to provide informed consent
  • Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexamethasone, dexmedetomidine
  • 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

Mslgorzata 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 Three Variants of PENG Block Using 20 mL of 0.2% Ropivacaine With Different Combinations of Dexamethasone and Perineural Dexmedetomidine in Patients Aged 65 Years and Older Undergoing Hip Surgery: A Randomized Controlled Trial.

This study will compare three different versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing surgery for hip conditions. The PENG block is a regional anesthesia technique that can reduce pain after surgery and decrease the need for strong opioid pain medications.

All patients in the study will receive the PENG block with 20 mL of 0.2% ropivacaine, but they will be divided into three groups based on the additional medications used:

Read more

Group 1: PENG block with ropivacaine plus 4 mg of dexamethasone given intravenously.

Group 2: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously.

Group 3: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves.

Both dexmedetomidine and dexamethasone are medications that may improve the strength and duration of nerve blocks.

The main goal of this study is to determine which combination provides the best pain control after hip surgery, reduces the need for opioid medications, and improves patient comfort and recovery. We also aim to evaluate the safety and side-effects of each technique.

We hypothesize that adding both dexmedetomidine and dexamethasone near the nerves will provide the longest and most effective pain relief when compared to intravenous administration alone.

This trial may help identify the most effective PENG block formula for older adults undergoing hip surgery and could improve pain management, decrease complications related to opioids, and support faster recovery.

Read the detailed description

Hip surgery in older adults is commonly associated with significant postoperative pain. Effective pain control is very important in this population because poorly controlled pain may lead to complications such as delayed rehabilitation, increased opioid use, delirium, and longer hospital stay. The Pericapsular Nerve Group (PENG) block is a modern regional anesthesia technique that targets nerves responsible for hip pain while preserving muscle strength around the hip. This may help patients recover faster and walk earlier after surgery.

Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of nerve blocks. Dexamethasone can be given either intravenously or near the nerves. Dexmedetomidine can also be given near the nerves in low doses to prolong pain relief. However, it is still unknown which combination of these medications with the PENG block provides the best results for older patients.

This study will compare three different versions of the PENG block in patients aged 65 years and older who are undergoing hip surgery. All participants will receive 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups depending on the additional medications they receive:

Group 1: PENG block with 4 mg of dexamethasone given intravenously. Group 2: PENG block with 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously.

Group 3: PENG block with 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves.

The main goal of the study is to determine which combination provides the most effective pain control after surgery. Pain intensity, opioid consumption, side effects, block duration, and time to first mobilization will be measured. The study will also assess safety, possible complications, and patient satisfaction.

We hypothesize that the combination of perineural dexmedetomidine and perineural dexamethasone will result in the longest duration of pain relief with minimal side effects and reduced need for opioids, when compared with intravenous administration.

This is a randomized controlled clinical trial. All patients will receive standard perioperative care. Participation in the study includes follow-up assessments after surgery to evaluate pain levels, medication requirements, and recovery.

The results of this trial may help identify the best regimen for the PENG block in older adults, improve postoperative pain management, reduce opioid-related complications, and support safer and faster rehabilitation after hip surgery.

Being tested
Dexamethasone (intravenous), Dexamethasone (intravenous) with Dexmedetomidine (perineural), Dexamethasone (perineural) with Dexmedetomidine (perineural)
Medical subject headings
Osteoarthritis, Hip

What participants receive

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

  • Dexamethasone (intravenous)Drug

    Perineural: 20 mL 0.2% ropivacaine + perineural placebo (normal saline) Intravenous: 4 mg dexamethasone + matching volume of saline if needed

  • Dexamethasone (intravenous) with Dexmedetomidine (perineural)Drug

    Perineural: 20 mL 0.2% ropivacaine + 25 µg dexmedetomidine (± saline to equalize volume) Intravenous: 4 mg dexamethasone

  • Dexamethasone (perineural) with Dexmedetomidine (perineural)Drug

    Perineural: 20 mL 0.2% ropivacaine + 25 µg dexmedetomidine + 4 mg dexamethasone Intravenous: placebo (0.9% normal saline)

Study groups in NCT07327931
Study groupRoleWhat they receive
PENG Block With Intravenous DexamethasoneActive comparatorParticipants will receive a Pericapsular Nerve Group (PENG) block using 20 mL of 0.2% ropivacaine. As part of the study medications, they will receive 4 mg of dexamethasone intravenously and perineural normal saline as placebo, so that the number and volume of injections are identical across all groups.
Receives: Drug: Dexamethasone (intravenous)
PENG Block With Perineural Dexmedetomidine and Intravenous DexamethasoneActive comparatorParticipants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine administered perineurally. In addition, they will receive 4 mg of dexamethasone intravenously. Perineural normal saline may be added to match the total volume of perineural injectate across groups.
Receives: Drug: Dexamethasone (intravenous) with Dexmedetomidine (perineural)
PENG Block With Perineural Dexmedetomidine and Perineural DexamethasoneExperimentalParticipants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine and 4 mg of dexamethasone administered perineurally. Intravenously they will receive normal saline as placebo instead of dexamethasone in order to maintain blinding.
Receives: Drug: Dexamethasone (perineural) with Dexmedetomidine (perineural)

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 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

Secondary outcomes (19)
  1. 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

  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: 8 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: 12 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: 24 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: 48 hours after surgery

  6. 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

  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: 8 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: 12 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: 24 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: 48 hours after surgery

  11. Total 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

  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. Hemodynamic Adverse Events (Hypotension and Bradycardia)

    Incidence of hypotension (e.g., systolic blood pressure <90 mmHg or decrease >30% from baseline) and bradycardia (heart rate <50 beats/min) requiring medical treatment. Events will be recorded and compared between groups.

    Measured: From block placement until 24 hours after surgery

  14. 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

  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: 4 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: 8 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: 12 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: 24 hours after surgery

  19. 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 48 hours after surgery

    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 start13 Feb 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Jan 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
NCT07327931
Sponsor's protocol ID
4/2025
Status last verified
Dec 2025
First submitted
28 Dec 2025
Last updated
22 May 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 Dexamethasone (intravenous), Dexamethasone (intravenous) with Dexmedetomidine (perineural) and Dexamethasone (perineural) with Dexmedetomidine (perineural) in people with Hip Osteoarthritis and Hip Pain Chronic, 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 22 May 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 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 22 May 2026.

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Clinical Trial NCT07327931 | AzTrials