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

NCT07284615 | Recruiting

• 1 other identifier: 5967
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Postoperative muscle weakness; ERAS; Regional Block

Outcome Measures

Primary Outcomes (1)

• Pain at rest control at 6h

  pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  six hours after performing the regional anesthesia technique

Secondary Outcomes (15)

• Pain at rest control at 24h

  24 hours after performing the regional anesthesia technique

• Pain at rest control at 48h

  48 hours after performing the regional anesthesia technique

• Pain on movement control at 6h

  six hours after performing the regional anesthesia technique

• Pain on movement control at 24h

  24 hours after performing the regional anesthesia technique

• Pain on movement control at 48h

  48 hours after performing the regional anesthesia technique

Study Arms (2)

PENG - LFCN Block

EXPERIMENTAL

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

Procedure: PENG plus LFCN block

PENG-WI

ACTIVE COMPARATOR

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.

Procedure: PENG plus WI

Interventions

PENG plus LFCN block 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.

Also known as: Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block

PENG - LFCN Block

PENG plus WI 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

Also known as: Pericapsular nerve group block and wound infiltration, PENG and WI

PENG-WI

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Edoardo Bassini: lead

Study Sites (1)

Ospedale Edoardo Bassini

Cinisello Balsamo, Milano, 20092, Italy

RECRUITING

Central Study Contacts

Matteo Coccolo, MD

CONTACT

0039025799; matteo.coccolo@asst-nordmilano.it

Angelo Pezzi, MD

CONTACT

0039025799; angelo.pezzi@asst-nordmilano.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: A double-blind, randomized, controlled trial

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 16, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)