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This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).
The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.
All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.
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| 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 10ml of Ropivacaine 0.5% will be administered respectively |
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| PENG-WI | Active Comparator | the group in which PENG and WI (wound infiltration) are performed, after neuraxial anesthesia, a PENG block will be administered under ultrasound guidance using 20 mL of 0.5% ropivacaine. At the end of the surgery, a wound infiltration will be performed with 10 mL of 0.5% ropivacaine. |
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| 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 |
|---|---|---|
| Pain at rest 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" | six hours after performing the regional anesthesia technique |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest 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 at rest control at 48h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Coccolo, MD | Contact | 0039025799 | 8271 | matteo.coccolo@asst-nordmilano.it |
| Angelo Pezzi, MD | Contact | 0039025799 | 8293 | angelo.pezzi@asst-nordmilano.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Edoardo Bassini | Recruiting | Cinisello Balsamo | Milano | 20092 | Italy |
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A double-blind, randomized, controlled trial
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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
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| PENG plus WI | Procedure | The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision |
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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 |
| Pain on movement 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" | six hours after performing the regional anesthesia technique |
| Pain on movement 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 on movement 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 |
| 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 |
| time to first PRN opioid request | Description: time to first PRN (pro re nata) opioid request expressed in minutes | Time Frame: From date of surgery until up to 48 hours after |
| MME of PRN opioid total doses | Description: 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 48 hours after |
| Complication | any complications recorded in the first 48 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity | From date of surgery until up to 48 hours after |
| the degree of hip flexion at 6h | 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 at 24h | 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 at 48h | Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position | 48 hours after performing the regional anesthesia technique |
| Length of Hospital Stay (LOS) | Length of hospital stay will be recorded as the number of postoperative midnights spent in the Orthopedic Ward, calculated from the day of surgery (postoperative day 0) until the date of discharge or death (exitus). | From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months |