Comparison of PENG Associated with LFCN Block Versus FICB for Multimodal Analgesic Management in THA

Pericapsular Nerve Group (PENG) Associated with Lateral Femoral Cutaneous Nerve (LFCN) Block Versus FIC Block for Total Hip Replacement Surgery: a Double Blind Randomized Controlled Trial

Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Regional Anesthesia Morbidity; Arthropathy of Hip; Hip Arthropathy; Anesthesia Complication
• Intervention / Treatment: Procedure: PENG plus LFCN block; Procedure: FIC Block

Detailed Description

This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee "Comitato Etico Territoriale Lombardia 3".

Each patient undergoing elective total hip replacement surgery with anterior approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized.

At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Cinisello Balsamo, Milano, Italy, 20092
      • Ospedale Edoardo Bassini

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• elective total hip replacement surgery for non-traumatic hip disease,
• THA (total hip arthroplasty) with lateral approach
• age >18 years,
• signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed

Exclusion Criteria:

• Non elective THA
• Lack of consent to the procedure
• Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000)
• 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 5ml 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: FIC Block; group in which FIC Block was performed After performing neuraxial anesthesia, FIC block will be performed. Under ultrasound guidance, 20 ml of Ropivacaine 0.5% will be administered.	Procedure: FIC Block; The control arm will be subjected to an interfascial block, the fascia iliaca Compartment Block. The FICB consists in the injection of anaesthetic agents into the fascia iliaca compartment.; Other Names: FICB; Fascia Iliaca Compartment Block

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first postoperative ambulation	we studied the effect or Regional anesthesia on residual paralysis	From date of surgery until up to 72 hours after
Pain 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 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 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
MME of PRN opioid total doses	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 72 hours after
time to first PRN opioid request	time to first PRN (pro re nata) opioid request expressed in minutes	From date of surgery until up to 72 hours after
need for PRN opioid	number of opioid administration	From date of surgery until up to 72 hours after

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	any complications recorded in the first 72 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity	From date of surgery until up to 72 hours after
the degree of hip flexion	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	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	Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position	48 hours after performing the regional anesthesia technique

Collaborators and Investigators

• Sponsor: Ospedale Edoardo Bassini

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ERAS; Post Operative Analgesia; Postoperative muscle weakness; Regional Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Joint Diseases
• Other Study ID Numbers: 3703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No