Liposomal Bupivacaine Fascia Iliaca Block for Perioperative Sleep Quality in Elderly Patients With Intertrochanteric Fracture

This is a prospective, randomized, placebo-controlled, double-blind, single-center trial. Eighty patients aged 65-80 years (ASA physical status II-III) scheduled for closed reduction and proximal femoral nail antirotation (PFNA) fixation of a unilateral intertrochanteric femoral fracture under intrathecal anesthesia are randomized 1:1 to two groups.

Immediately after enrollment on admission, the intervention group (Group Z) receives an ultrasound-guided suprainguinal fascia iliaca compartment block (FICB) with liposomal bupivacaine 133 mg diluted to 40 mL with normal saline; the control group (Group D) receives 40 mL of normal saline by the identical technique. The block is performed by a single experienced anesthesiologist using a high-frequency linear probe and an in-plane technique, with the "hill sign" view (subcutaneous tissue, abdominal wall muscles, fascia iliaca, iliacus muscle, and ilium) confirming correct injection between the fascia iliaca and the iliacus muscle. Sensory blockade is assessed 20 minutes after injection by a blinded anesthesiologist using pinprick in the femoral, obturator, and lateral femoral cutaneous nerve territories; results are sealed and not used for clinical decisions until unblinding.

Both groups receive identical multimodal baseline analgesia (intravenous dexketoprofen trometamol 100 mg twice daily until the day of surgery), identical standardized spinal anesthesia (0.75% bupivacaine 1 mL diluted to 3 mL with cerebrospinal fluid at L3-4) with intraoperative dexmedetomidine infusion (0.3 microgram/kg/h), standardized hemodynamic management, and identical postoperative sufentanil-based patient-controlled intravenous analgesia (PCIA; sufentanil 1 microgram/kg in 150 mL, background 2 mL/h, bolus 2 mL, lockout 15 min). Rescue analgesia (intramuscular tramadol 50 mg) is given when resting VAS >= 4 despite PCIA.

Randomization is performed with an online random number generator (Research Randomizer) with allocation concealment using sealed opaque envelopes opened only by the study-drug preparation nurse, who does not participate in block performance, outcome assessment, or data analysis. Participants, the anesthesiologist performing the block, outcome assessors, and the statistician are blinded to group allocation.

The primary outcome is the Leeds Sleep Evaluation Questionnaire (LSEQ) score on the night of admission (the first night after the intervention). Secondary outcomes include LSEQ scores on the night of surgery and the second postoperative night, objective sleep parameters derived from a wrist-worn activity tracker (Fitbit Charge 6), anxiety scores, postoperative pain scores, perioperative sufentanil consumption, rescue analgesia, incidence of postoperative delirium (assessed twice daily on postoperative days 1-3 with the Confusion Assessment Method), time to first ambulation, postoperative length of stay, and adverse events.

The planned sample size of 40 per group provides 80% power (two-sided alpha = 0.05) to detect a between-group difference of approximately 34 points in the primary outcome assuming a pooled standard deviation of 52 points (based on an internal pilot study), allowing for 10% attrition.