Ospedale Edoardo Bassini
Cinisello Balsamo, Milano, 20092, Italy
Location status: Recruiting
NCT Number: NCT07284615
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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All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block
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
Other names: Pericapsular nerve group block and wound infiltration, PENG and WI
Time frame: 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 frame: 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"
Time frame: 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 frame: 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 frame: 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"
Time frame: 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 frame: 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".
Time frame: 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".
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: six hours after performing the regional anesthesia technique
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Time frame: 24 hours after performing the regional anesthesia technique
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Time frame: 48 hours after performing the regional anesthesia technique
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Ospedale Edoardo Bassini
Other
Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
Acronym: Peng_lfcn/WI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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