Skip to main content
OpenTrials
Completed

NCT Number: NCT06147401

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Regional Anesthesia Morbidity Anesthesia Complication Arthropathy of Hip Hip Arthropathy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Edoardo Bassini

Cinisello Balsamo, Milano, 20092, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block

FIC block

Procedure

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: Fascia Iliaca Compartment Block, FICB

Primary outcomes

  1. MRC at 6h

    Time frame: six hours after performing the regional anesthesia technique

    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".

  2. MRC at 24h

    Time frame: 24 hours after performing the regional anesthesia technique

    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".

  3. MRC at 48h

    Time frame: 48 hours after performing the regional anesthesia technique

    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".

Secondary outcomes

  1. time to first postoperative ambulation

    Time frame: From date of surgery until up to 72 hours after

    we studied the effect or Regional anesthesia on residual paralysis

  2. Pain control at 6h

    Time frame: six hours after performing the regional anesthesia technique

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

  3. Pain control at 24h

    Time frame: 24 hours after performing the regional anesthesia technique

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

  4. Pain control at 48h

    Time frame: 48 hours after performing the regional anesthesia technique

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

  5. MME of PRN opioid total doses

    Time frame: From date of surgery until up to 72 hours after

    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

  6. time to first PRN opioid request

    Time frame: From date of surgery until up to 72 hours after

    time to first PRN (pro re nata) opioid request expressed in minutes

  7. need for PRN opioid

    Time frame: From date of surgery until up to 72 hours after

    number of opioid administration

Other outcomes

  1. Complication

    Time frame: From date of surgery until up to 72 hours after

    any complications recorded in the first 72 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity

  2. the degree of hip flexion

    Time frame: six hours after performing the regional anesthesia technique

    Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position

  3. the degree of hip flexion

    Time frame: 24 hours after performing the regional anesthesia technique

    Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position

  4. the degree of hip flexion

    Time frame: 48 hours after performing the regional anesthesia technique

    Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position

Sponsors and collaborators

Lead sponsor

Ospedale Edoardo Bassini

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.