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

NCT07330999 | Recruiting

• 1 other identifier: 10/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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: 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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (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).

  Within 48 hours after 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 Ropivacaine Only (Control)

ACTIVE COMPARATOR

Participants 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.

Drug: Ropivacaine 0.2% Injectable Solution

PENG Block With Perineural Dexamethasone

ACTIVE COMPARATOR

Participants 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.

Drug: Dexamethasone 4mg

PENG Block With Perineural Dexmedetomidine

ACTIVE COMPARATOR

Participants 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.

Drug: Dexmedetomidine

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

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.

PENG Block With Ropivacaine Only (Control)

Dexamethasone 4mg DRUG

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

PENG Block With Perineural Dexamethasone

Dexmedetomidine DRUG

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

PENG Block With Perineural 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
• 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

You may not qualify if:

• 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
• 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

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; Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; 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
• Masking Details: Study medications will be prepared by a clinician not involved in patient care or outcome assessment. All participants will receive identical appearing syringes and identical volumes of perineural and intravenous solutions containing either active medication or normal saline placebo. Patients, care providers, investigators, and outcome assessors will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available beginning 12 months after publication of the primary results and will remain available for 5 years after publication.
• Access Criteria: Data will be shared with qualified researchers for scientific purposes upon reasonable request. Requests will be evaluated by the study investigators. A data sharing agreement may be required.

Locations

PL (1)