PENG Block With Dexmedetomidine in Older Adults

NCT07327372 | Recruiting

• 1 other identifier: 16/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Regional anesthesia techniques are increasingly used to improve pain control while reducing the use of systemic opioids. The pericapsular nerve group (PENG) block is a modern ultrasound-guided regional anesthesia technique designed to provide effective pain relief after hip surgery while preserving muscle strength. It allows patients to begin mobilization earlier and may reduce the risk of postoperative complications, which is particularly important in older adults. Ropivacaine is a commonly used local anesthetic for nerve blocks. Dexmedetomidine is a medication that, when added in small doses to local anesthetics, may prolong pain relief and improve the quality of nerve blocks without significantly increasing side effects. However, the benefits and safety of adding dexmedetomidine to the PENG block in older adults have not been sufficiently studied. The aim of this randomized controlled clinical study is to compare the effectiveness and safety of two PENG block techniques in older adults undergoing hip surgery. Participants will be randomly assigned to one of two groups. One group will receive a PENG block with 20 mL of 0.2% ropivacaine. The second group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine. The study hypothesis is that the addition of dexmedetomidine to ropivacaine in the PENG block will provide longer-lasting and more effective postoperative pain relief compared with ropivacaine alone, without increasing adverse effects. Outcomes assessed in the study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of side effects such as low blood pressure, slow heart rate, excessive sedation, or delirium. The results of this study may help optimize regional anesthesia techniques for hip surgery in older adults and contribute to safer, more effective postoperative pain management strategies.

Conditions

Hip Osteoarthritis; Arthropathy of Hip

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 (12)

• 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 (2)

PENG Block With Ropivacaine

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2%, total volume 20 mL, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist.

Drug: Ropivacaine 0.2% Injectable Solution

PENG Block With Ropivacaine Plus Dexmedetomidine

EXPERIMENTAL

Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2% (20 mL) combined with dexmedetomidine 25 micrograms, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist.

Drug: Dexmedetomidine

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

Ropivacaine is a long-acting local anesthetic used for regional anesthesia. In this study, it is administered perineurally as part of an ultrasound-guided pericapsular nerve group (PENG) block for postoperative pain management in older adults undergoing hip surgery.

Also known as: Ropivacaine hydrochloride

PENG Block With Ropivacaine

Dexmedetomidine DRUG

Dexmedetomidine is a selective alpha-2 adrenergic agonist used as an adjuvant to local anesthetics to enhance and prolong analgesia. In this study, dexmedetomidine is administered perineurally in combination with ropivacaine as part of an ultrasound-guided pericapsular nerve group (PENG) block.

Also known as: Dexmedetomidine hydrochloride

PENG Block With Ropivacaine Plus Dexmedetomidine

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, 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

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata 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 6, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after publication
• Access Criteria: Upon reasonable request

Locations

PL (1)