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

NCT06147401 | Completed

• 1 other identifier: 3703
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Regional Anesthesia Morbidity; Arthropathy of Hip; Hip Arthropathy; Post Operative Pain; Anesthesia Complication

Keywords

ERAS; Postoperative muscle weakness; Regional Block; Post Operative Analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• time to first postoperative ambulation

  From date of surgery until up to 72 hours after

• Pain control at 6h

  six hours after performing the regional anesthesia technique

• Pain control at 24h

  24 hours after performing the regional anesthesia technique

• Pain control at 48h

  48 hours after performing the regional anesthesia technique

• MME of PRN opioid total doses

  From date of surgery until up to 72 hours after

Other Outcomes (4)

• Complication

  From date of surgery until up to 72 hours after

• the degree of hip flexion

  six hours after performing the regional anesthesia technique

• the degree of hip flexion

  24 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 5ml of Ropivacaine 0.5% will be administered respectively.

Procedure: PENG plus LFCN block

FIC Block

ACTIVE COMPARATOR

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

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

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.

Also known as: Fascia Iliaca Compartment Block, FICB

FIC Block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Edoardo Bassini: lead

Study Sites (1)

Ospedale Edoardo Bassini

Cinisello Balsamo, Milano, 20092, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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: Principal Investigator

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

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 27, 2023
• Study Start: November 20, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

IT (1)