PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

NCT07327931 | Recruiting

• 1 other identifier: 4/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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: 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.

Conditions

Hip Osteoarthritis; Hip Pain Chronic

Outcome Measures

Primary Outcomes (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.

  Within 48 hours after the end of surgery

Secondary Outcomes (19)

• Pain Intensity at Rest (NRS 0-10)

  4 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  8 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  12 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  24 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  48 hours after surgery

Study Arms (3)

PENG Block With Intravenous Dexamethasone

ACTIVE COMPARATOR

Participants 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.

Drug: Dexamethasone (intravenous)

PENG Block With Perineural Dexmedetomidine and Intravenous Dexamethasone

ACTIVE COMPARATOR

Participants 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.

Drug: Dexamethasone (intravenous) with Dexmedetomidine (perineural)

PENG Block With Perineural Dexmedetomidine and Perineural Dexamethasone

EXPERIMENTAL

Participants 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.

Drug: Dexamethasone (perineural) with Dexmedetomidine (perineural)

Interventions

Dexamethasone (intravenous) with Dexmedetomidine (perineural) DRUG

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

PENG Block With Perineural Dexmedetomidine and Intravenous Dexamethasone

Dexamethasone (intravenous) DRUG

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

PENG Block With Intravenous 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)

PENG Block With Perineural Dexmedetomidine and Perineural Dexamethasone

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Malgorzata Reysner

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available beginning 6 months after publication of the primary results and will remain available for 5 years following publication.
• Access Criteria: Access to the data will be granted to researchers who provide a methodologically sound research proposal. Requests must be approved by the principal investigator and the local ethics committee, if required. Data will be shared under a data use agreement and may be used only for non-commercial scientific research purposes.

Locations

PL (1)