PENG Block Optimization: Volume and Dexamethasone Effects

NCT ID: NCT07023120

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Hip Arthropathy Hip Osteoarthritis Hip Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PENG 20 mL

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

20ml 0.2% Ropivacaine

PENG 20 mL + DEX

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

20ml 0.2% Ropivacaine

Dexamethasone 4mg

Intervention Type DRUG

perineural 4mg Dexamethasone

PENG 10 mL

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

10ml 0.2% Ropivacaine

PENG 10 mL + DEX

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

Group Type ACTIVE_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

perineural 4mg Dexamethasone

Ropivacaine 0.2% Injectable Solution

Intervention Type DRUG

10ml 0.2% Ropivacaine

Interventions

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Ropivacaine 0.2% Injectable Solution

20ml 0.2% Ropivacaine

Intervention Type DRUG

Dexamethasone 4mg

perineural 4mg Dexamethasone

Intervention Type DRUG

Ropivacaine 0.2% Injectable Solution

10ml 0.2% Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Reysner, M.D. Ph.D.

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Tomasz Reysner, M.D. Ph.D.

Role: CONTACT

+48 (61) 873-83-03

Malgorzata Reysner, M.D. Ph.D.

Role: CONTACT

+48 (61) 873-83-03

Facility Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: primary

Other Identifiers

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8/2025

Identifier Type: -

Identifier Source: org_study_id

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