Arthropathy of Hip, Complication of Anesthesia, Hip Arthropathy, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge, Locoregional Anesthesia, Opioid Consumption, Regional Anesthesia Morbidity
Conditions
Keywords
Postoperative muscle weakness, ERAS, Regional Block
Brief summary
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.
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.
PROCEDUREPENG plus WI
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
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
* Age \> 18 years * Elective total hip arthroplasty * Spinal (subarachnoid) anesthesia * Written informed consent provided by the patient or by the legal guardian, if appointed
Exclusion criteria
* INR \> 1.5 * aPTT \> 1.5 * Platelet count \< 75,000/mm³ * Signs suggestive of infection at the puncture site * Absence of informed consent to the procedure * Documented or suspected allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest 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" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest 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 at rest 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" |
| Pain on movement 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 on movement 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 on movement 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" |
| 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". |
| time to first PRN opioid request | Time Frame: From date of surgery until up to 48 hours after | Description: time to first PRN (pro re nata) opioid request expressed in minutes |
| MME of PRN opioid total doses | From date of surgery until up to 48 hours after | 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 |
| Complication | From date of surgery until up to 48 hours after | any complications recorded in the first 48 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity |
| the degree of hip flexion at 6h | 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 at 24h | 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 at 48h | 48 hours after performing the regional anesthesia technique | Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position |
| Length of Hospital Stay (LOS) | 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 | 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). |
Countries
Italy
Contacts
CONTACTMatteo Coccolo, MD
CONTACTAngelo Pezzi, MD
Outcome results
None listed