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

Post Operative Pain Clinical Trial

Official title:

Comparison of Pericapsular Nerve Group (PENG) Block Associated With Lateral Femoral Cutaneous Nerve (LFCN) Block Versus Fascia Iliaca Compartment Block (FICB) for Multimodal Analgesic Management in Total Hip Replacement Surgery: a Double-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147401
• Other study ID #: 3703
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Ospedale Edoardo Bassini
• Contact: Francesco Vetrone, MD
• Phone: 0039025799
• Email: francesco.vetrone[@]asst-nordmilano.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 lateral 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Arthropathy of Hip
• Hip Arthropathy
• Joint Diseases
• Pain, Postoperative
• Post Operative Pain
• Regional Anesthesia Morbidity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Edoardo Bassini	Cinisello Balsamo	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Edoardo Bassini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	need for PRN opioid	number of opioid administration	From date of surgery until up to 72 hours after