Comparison of PENG Associated With LFCN Block Versus FICB for Multimodal Analgesic Management in THA
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PENG - 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. |
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.
Other Names:
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| Active Comparator: 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. |
Procedure: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 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".
- 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".
Secondary Outcome Measures
- 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"
- 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
- need for PRN opioid [From date of surgery until up to 72 hours after]
number of opioid administration
Other Outcome Measures
- Complication [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
- the degree of hip flexion [six hours after performing the regional anesthesia technique]
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
- the degree of hip flexion [24 hours after performing the regional anesthesia technique]
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
- the degree of hip flexion [48 hours after performing the regional anesthesia technique]
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Eligibility Criteria
Criteria
Inclusion Criteria:
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elective total hip replacement surgery for non-traumatic hip disease,
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THA (total hip arthroplasty) with lateral approach
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age >18 years,
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signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed
Exclusion Criteria:
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Non elective THA
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Lack of consent to the procedure
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Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000)
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Documented or suspected allergy to local anesthetics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale Edoardo Bassini | Cinisello Balsamo | Milano | Italy | 20092 |
Sponsors and Collaborators
- Ospedale Edoardo Bassini
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3703