Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

NCT ID: NCT07284615

Last Updated: 2025-12-16

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-11-30

Brief Summary

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This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).

The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.

All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.

Detailed Description

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Conditions

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Arthropathy of Hip Hip Arthropathy Locoregional Anesthesia Complication of Anesthesia Regional Anesthesia Morbidity Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge Opioid Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blind, randomized, controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The anesthetist in the operating room will be the only one who knows what treatment has been administered

Participant: the patient will not know the type of block he will be subjected to, because of he will already be subjected to neuraxial anesthesia.

Outcomes Assessor: a clinician external to the practice will evaluate the degree of residual paralysis after anesthesia and pain control Investigator: the statistician will not know which anesthetic technique was administered to which group

Study Groups

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PENG-WI

the group in which PENG and WI (wound infiltration) are performed, after neuraxial anesthesia, a PENG block will be administered under ultrasound guidance using 20 mL of 0.5% ropivacaine. At the end of the surgery, a wound infiltration will be performed with 10 mL of 0.5% ropivacaine.

Group Type ACTIVE_COMPARATOR

PENG plus WI

Intervention Type PROCEDURE

The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision

PENG - LFCN Block

group in which PENG and LFCN Block was performed. After performing neuraxial anesthesia, the PENG associated with LFCN block will be performed. Under ultrasound guidance, 20ml and 10ml of Ropivacaine 0.5% will be administered respectively

Group Type EXPERIMENTAL

PENG plus LFCN block

Intervention Type PROCEDURE

The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.

Interventions

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PENG plus LFCN block

The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.

Intervention Type PROCEDURE

PENG plus WI

The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision

Intervention Type PROCEDURE

Other Intervention Names

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Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block Pericapsular nerve group block and wound infiltration, PENG and WI

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Elective total hip arthroplasty
* Spinal (subarachnoid) anesthesia
* Written informed consent provided by the patient or by the legal guardian, if appointed

Exclusion Criteria

* INR \> 1.5
* aPTT \> 1.5
* Platelet count \< 75,000/mm³
* Signs suggestive of infection at the puncture site
* Absence of informed consent to the procedure
* Documented or suspected allergy to local anesthetics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Edoardo Bassini

OTHER

Sponsor Role lead

Responsible Party

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Matteo Coccolo

Medical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Edoardo Bassini

Cinisello Balsamo, Milano, Italy

Site Status

Countries

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Italy

Central Contacts

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Matteo Coccolo, MD

Role: CONTACT

0039025799 ext. 8271

Angelo Pezzi, MD

Role: CONTACT

0039025799 ext. 8293

Other Identifiers

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5967

Identifier Type: -

Identifier Source: org_study_id