Clinical trial NCT06147401: Comparison of PENG Associated with LFCN Block Versus FICB for Multimodal Analgesic Management in THA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Arthropathy of Hip
Hip Arthropathy
Post Operative Pain
Anesthesia Complication
Keywords: ERAS
Postoperative muscle weakness
Regional Block
Post Operative Analgesia
Lead sponsor: Ospedale Edoardo Bassini
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, randomized, controlled trial
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRC at 6h
timeFrame: six hours after performing the regional anesthesia technique
measure: MRC at 24h
timeFrame: 24 hours after performing the regional anesthesia technique
measure: MRC at 48h
timeFrame: 48 hours after performing the regional anesthesia technique
Secondary outcomes:
measure: time to first postoperative ambulation
timeFrame: From date of surgery until up to 72 hours after
measure: Pain control at 6h
timeFrame: six hours after performing the regional anesthesia technique
measure: Pain control at 24h
timeFrame: 24 hours after performing the regional anesthesia technique
measure: Pain control at 48h
timeFrame: 48 hours after performing the regional anesthesia technique
measure: MME of PRN opioid total doses
timeFrame: From date of surgery until up to 72 hours after
measure: time to first PRN opioid request
timeFrame: From date of surgery until up to 72 hours after
measure: need for PRN opioid
timeFrame: From date of surgery until up to 72 hours after
Other outcomes:
measure: Complication
timeFrame: From date of surgery until up to 72 hours after
measure: the degree of hip flexion
timeFrame: six hours after performing the regional anesthesia technique
measure: the degree of hip flexion
timeFrame: 24 hours after performing the regional anesthesia technique
measure: the degree of hip flexion
timeFrame: 48 hours after performing the regional anesthesia technique
Locations:
city: Cinisello Balsamo
country: Italy
facility: Ospedale Edoardo Bassini
state: Milano
Study officials:
References: