Anesthesia Complication, Arthropathy of Hip, Hip Arthropathy, Post Operative Pain, Regional Anesthesia Morbidity
Conditions
Keywords
ERAS, Postoperative muscle weakness, Regional Block, Post Operative Analgesia
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.
Interventions
PROCEDUREPENG 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.
PROCEDUREFIC 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.
Sponsors
Ospedale Edoardo Bassini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
A double-blind, randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed