Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| time to first postoperative ambulation | we studied the effect or Regional anesthesia on residual paralysis | From date of surgery until up to 72 hours after |
| Pain control at 6h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | any complications recorded in the first 72 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity | From date of surgery until up to 72 hours after |
| the degree of hip flexion |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Edoardo Bassini | Cinisello Balsamo | Milano | 20092 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A double-blind, randomized, controlled trial
Not provided
Not provided
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
|
|
| 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. |
|
|
| six hours after performing the regional anesthesia technique |
| Pain control at 24h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" | 24 hours after performing the regional anesthesia technique |
| Pain control at 48h | pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" | 48 hours after performing the regional anesthesia technique |
| MME of PRN opioid total doses | 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 | From date of surgery until up to 72 hours after |
| time to first PRN opioid request | time to first PRN (pro re nata) opioid request expressed in minutes | From date of surgery until up to 72 hours after |
| need for PRN opioid | number of opioid administration | From date of surgery until up to 72 hours after |
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
| six hours after performing the regional anesthesia technique |
| the degree of hip flexion | Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position | 24 hours after performing the regional anesthesia technique |
| the degree of hip flexion | Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position | 48 hours after performing the regional anesthesia technique |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided