PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

NCT ID: NCT07327931

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-31

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.

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.

Conditions

Hip Osteoarthritis; Hip Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PENG Block With Intravenous Dexamethasone

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone (intravenous)

Intervention Type: DRUG

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

PENG Block With Perineural Dexmedetomidine and Intravenous Dexamethasone

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone (intravenous) with Dexmedetomidine (perineural)

Intervention Type: DRUG

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

PENG Block With Perineural Dexmedetomidine and Perineural Dexamethasone

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.

Group Type: EXPERIMENTAL

Dexamethasone (perineural) with Dexmedetomidine (perineural)

Intervention Type: DRUG

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

Interventions

Dexamethasone (intravenous)

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

Intervention Type: DRUG

Dexamethasone (intravenous) with Dexmedetomidine (perineural)

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

Intervention Type: DRUG

Dexamethasone (perineural) with Dexmedetomidine (perineural)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malgorzata Reysner

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Locations

Poznan University of Medical Sciences

Poznan, , Poland

Countries

Poland

Central Contacts

Malgorzata Reysner, MD PhD

Role: CONTACT

mreysner@ump.edu.pl

+48 61 873 83 03

Mslgorzata Reysner, MD PhD

Role: CONTACT

mreysner@ump.edu.pl

+48 61 873 83 03

Other Identifiers

4/2025

Identifier Type: -

Identifier Source: org_study_id