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 (Peng_lfcn/WI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Regional Anesthesia Morbidity; Arthropathy of Hip; Opioid Consumption; Hip Arthropathy; Complication of Anesthesia; Locoregional Anesthesia; Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge
• Intervention / Treatment: Procedure: PENG plus LFCN block; Procedure: PENG plus WI

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelo Pezzi, MD; Phone Number: 8293 0039025799; Email: angelo.pezzi@asst-nordmilano.it
• Study Contact Backup: Name: Matteo Coccolo, MD; Phone Number: 8271 0039025799; Email: matteo.coccolo@asst-nordmilano.it

Study Locations

• Italy
  • Milano
    • Cinisello Balsamo, Milano, Italy, 20092
      • Recruiting
      • Ospedale Edoardo Bassini
      • Contact: Matteo Coccolo, MD; Phone Number: 8271 +39025799; Email: matteo.coccolo@asst-nordmilano.it
      • Contact: Angelo Pezzi, MD; Phone Number: 8293 +39025799; Email: angelo.pezzi@asst-nordmilano.it
      • Principal Investigator: Matteo Coccolo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.; Other Names: Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block
Active Comparator: 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.	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; Other Names: Pericapsular nerve group block and wound infiltration, PENG and WI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRC at 6h	evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".	six hours after performing the regional anesthesia technique
MRC at 24h	evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".	24 hours after performing the regional anesthesia technique
MRC at 48h	evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".	48 hours after performing the regional anesthesia technique
Pain at rest control at 24h	pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	24 hours after performing the regional anesthesia technique
Pain at rest control at 48h	pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	48 hours after performing the regional anesthesia technique
Pain on movement 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
Pain on movement control at 24h	pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	24 hours after performing the regional anesthesia technique
Pain on movement control at 48h	pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	48 hours after performing the regional anesthesia technique
time to first PRN opioid request	Description: time to first PRN (pro re nata) opioid request expressed in minutes	Time Frame: From date of surgery until up to 48 hours after
MME of PRN opioid total doses	Description: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid total doses we will study the effect of Regional anesthesia on opioid-sparing with the same pre-established pain relief protocol	From date of surgery until up to 48 hours after
Complication	any complications recorded in the first 48 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity	From date of surgery until up to 48 hours after
the degree of hip flexion at 6h	Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position	six hours after performing the regional anesthesia technique
the degree of hip flexion at 24h	Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position	24 hours after performing the regional anesthesia technique
the degree of hip flexion at 48h	Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position	48 hours after performing the regional anesthesia technique
Length of Hospital Stay (LOS)	Length of hospital stay will be recorded as the number of postoperative midnights spent in the Orthopedic Ward, calculated from the day of surgery (postoperative day 0) until the date of discharge or death (exitus).	From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

Collaborators and Investigators

• Sponsor: Ospedale Edoardo Bassini

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ERAS; Postoperative muscle weakness; Regional Block
• Other Study ID Numbers: 5967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No