PENG Block Optimization: Volume and Dexamethasone Effects

Phase 4

Recruiting

• Conditions: Hip Arthropathy; Hip Osteoarthritis; Hip Arthritis
• Interventions: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Dexamethasone 4mg

• Registration Number: NCT07023120
• Lead Sponsor: Poznan University of Medical Sciences

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.

Detailed Description

The pericapsular nerve group (PENG) block has become a widely used motor-sparing component of multimodal analgesia for total hip arthroplasty (THA). However, its optimal formulation-particularly the volume of local anesthetic and the role of adjuvants-remains undetermined. This prospective, double-blind, randomized controlled trial evaluates the influence of ropivacaine volume (10 mL vs. 20 mL of 0.2%) and the addition of perineural dexamethasone (4 mg) on analgesic efficacy, opioid consumption, systemic inflammation, and quadriceps strength preservation.

A total of 120 adult patients undergoing unilateral THA under spinal anesthesia were randomized to one of four PENG block groups:

Group 1: 20 mL of 0.2% ropivacaine (standard-volume PENG) Group 2: 20 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone Group 3: 10 mL of 0.2% ropivacaine (low-volume PENG) Group 4: 10 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone The primary outcome was the time to first rescue opioid analgesia. Secondary outcomes included total 48-hour opioid consumption (expressed in oral morphine equivalents), numeric rating scale (NRS) pain scores, quadriceps muscle strength, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) at 12, 24, and 48 hours postoperatively.

Results demonstrated that the addition of dexamethasone, regardless of volume, significantly prolonged the duration of analgesia and reduced opioid consumption compared to non-adjuvanted PENG blocks. The low-volume + dexamethasone group achieved comparable analgesia to high-volume protocols with better inflammatory profiles. Quadriceps strength was preserved in all groups. These findings support the use of perineural dexamethasone as an effective enhancer of PENG block analgesia while enabling lower local anesthetic volume, potentially improving safety and recovery outcomes in THA patients.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Study First Posted: 2025-06-15
• Study Start: 2025-06-25
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG 20 mL	Ropivacaine 0.2% Injectable Solution	Ultrasound-guided PENG block - 20ml 0,2% ropivacaine
PENG 10 mL	Ropivacaine 0.2% Injectable Solution	Ultrasound-guided PENG block - 10ml 0,2% ropivacaine
PENG 20 mL + DEX	Ropivacaine 0.2% Injectable Solution	Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone
PENG 20 mL + DEX	Dexamethasone 4mg	Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone
PENG 10 mL + DEX	Dexamethasone 4mg	Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone
PENG 10 mL + DEX	Ropivacaine 0.2% Injectable Solution	Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone

Primary Outcome Measures

Name	Time	Method
Time to first rescue opioid	24 hours after surgery	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
blood glucose	48 hours after surgery	blood glucose level
Total 48h opioid consumption	48 hours after surgery	Total opiate consumption after surgery
Numerical Rating Scale [range 0:10]	48 hours after surgery	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
NLR	48 hours after surgery	neutrophile-to-lymphocyte ratio
PLR	48 hours after surgery	platelet-to-lymphocyte ratio
Quadriceps strength	48 hours after surgery	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Nerve damage	48 hours after surgery	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland