Comparison of PENG Associated with LFCN Block Versus FICB for Multimodal Analgesic Management in THA
- Conditions
- Arthropathy of HipRegional Anesthesia MorbidityAnesthesia ComplicationPost Operative PainHip Arthropathy
- Interventions
- Procedure: PENG plus LFCN blockProcedure: FIC Block
- Registration Number
- NCT06147401
- Lead Sponsor
- Ospedale Edoardo Bassini
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PENG - LFCN Block PENG plus 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. FIC Block 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.
- Primary Outcome Measures
Name Time Method MRC at 6h 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".
MRC at 48h 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".
MRC at 24h 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".
- Secondary Outcome Measures
Name Time Method MME of PRN opioid total doses 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
time to first PRN opioid request From date of surgery until up to 72 hours after time to first PRN (pro re nata) opioid request expressed in minutes
time to first postoperative ambulation From date of surgery until up to 72 hours after we studied the effect or Regional anesthesia on residual paralysis
Pain control at 6h 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"
Pain control at 24h 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"
Pain control at 48h 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"
need for PRN opioid From date of surgery until up to 72 hours after number of opioid administration
Trial Locations
- Locations (1)
Ospedale Edoardo Bassini
🇮🇹Cinisello Balsamo, Milano, Italy