PENG Block Optimization: Volume and Dexamethasone Effects

NCT07023120 | Completed Phase 4

• 1 other identifier: 8/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial investigates the impact of local anesthetic volume and perineural dexamethasone on the analgesic and anti-inflammatory effectiveness of the pericapsular nerve group (PENG) block in patients undergoing total hip arthroplasty (THA). Patients were randomized to receive one of four PENG block variants differing in ropivacaine volume (10 mL or 20 mL of 0.2%) and the addition of 4 mg of perineural dexamethasone. The study evaluates postoperative pain, opioid requirements, systemic inflammatory markers, and quadriceps motor preservation.

Conditions

Hip Arthritis; Hip Arthropathy; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Time to first rescue opioid

  Time after surgery when the patient needs opiate for the first time

  24 hours after surgery

Secondary Outcomes (23)

• Total 48h opioid consumption

  48 hours after surgery

• Numerical Rating Scale [range 0:10]

  4 hours after surgery

• Numerical Rating Scale [range 0:10]

  8 hours after surgery

• Numerical Rating Scale [range 0:10]

  12 hours after surgery

• Numerical Rating Scale [range 0:10]

  24 hours after surgery

Study Arms (4)

PENG 20 mL

ACTIVE COMPARATOR

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution

PENG 20 mL + DEX

ACTIVE COMPARATOR

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone

Drug: Ropivacaine 0.2% Injectable Solution; Drug: Dexamethasone 4mg

PENG 10 mL

ACTIVE COMPARATOR

Ultrasound-guided PENG block - 10ml 0,2% ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution

PENG 10 mL + DEX

ACTIVE COMPARATOR

Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone

Drug: Dexamethasone 4mg; Drug: Ropivacaine 0.2% Injectable Solution

Interventions

Dexamethasone 4mg DRUG

perineural 4mg Dexamethasone

PENG 10 mL + DEX; PENG 20 mL + DEX

Ropivacaine 0.2% Injectable Solution DRUG

20ml 0.2% Ropivacaine

PENG 20 mL; PENG 20 mL + DEX

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).
• American Society of Anesthesiologists (ASA) physical status I-III.
• Ability to provide written informed consent.
• Spinal anesthesia planned as the primary anesthetic technique.
• Body mass index (BMI) between 18 and 35 kg/m².
• Fluent in the local language and able to understand the NRS pain scoring system.

You may not qualify if:

• Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.
• Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.
• Chronic opioid use (daily use \>30 mg oral morphine equivalents for \>1 month prior to surgery).
• History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.
• Uncontrolled diabetes mellitus (HbA1c \> 9%) or active systemic infection.
• Pregnancy or breastfeeding.
• Previous surgery or implantation on the ipsilateral hip.
• Inability to cooperate with postoperative assessments or participate in follow-up.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Ropivacaine; Dexamethasone

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

Study Officials

• Malgorzata Reysner, M.D. Ph.D.

  Poznan University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: June 8, 2025
• First Posted: June 15, 2025
• Study Start: June 25, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 20, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-06

Locations

PL (1)