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

Effect of Preemptive Analgesia With Liposomal Bupivacaine Fascia Iliaca Compartment Block on Perioperative Sleep Quality, Anxiety, and Postoperative Delirium in Elderly Patients Undergoing Intertrochanteric Fracture Surgery: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Single-Center Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07892859
Enrollment
80
Registered
2026-10-23
Start date
2026-01-01
Completion date
2026-09-10
Last updated
2026-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intertrochanteric Fractures, Hip Fractures, Sleep Disturbance, Postoperative Delirium, Anxiety

Keywords

liposomal bupivacaine, fascia iliaca compartment block, preemptive analgesia, sleep quality, elderly, hip fracture, postoperative delirium

Brief summary

Older adults with hip fracture often experience severe pain before and after surgery. This pain can cause anxiety and poor sleep, and may increase the risk of postoperative delirium (sudden confusion after surgery). A fascia iliaca compartment block (FICB) is an injection of numbing medicine near the hip nerves that relieves pain, but standard numbing medicines only last about 8 to 12 hours. Liposomal bupivacaine is a long-acting form of a numbing medicine that may relieve pain for up to 72 hours after a single injection. This study tests whether giving an ultrasound-guided FICB with liposomal bupivacaine immediately after hospital admission (before surgery) improves sleep quality, reduces anxiety and pain, lowers the need for opioid pain medicines, and reduces postoperative delirium in patients aged 65 to 80 years undergoing surgery for intertrochanteric hip fracture, compared with a placebo (saline) injection. All participants in both groups receive the same standard pain treatment, including scheduled intravenous dexketoprofen and patient-controlled analgesia after surgery.

Detailed description

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.

Interventions

1.Arm 1 - Experimental: Liposomal bupivacaine group (Group Z) * Intervention (Drug): Liposomal Bupivacaine * Description: Single ultrasound-guided suprainguinal FICB injection of liposomal bupivacaine 133 mg/10 mL diluted to 40 mL with 0.9% saline, injected between the fascia iliaca and iliacus muscle.

2.Arm 2 - Placebo Comparator: Saline group (Group D) * Intervention (Drug): Normal saline * Description: Single ultrasound-guided suprainguinal FICB injection of 40 mL 0.9% sodium chloride solution (placebo).

Sponsors

Li Xiaoyuan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The study drug (milky-white liposomal bupivacaine dilution) and the placebo (clear normal saline) differ in appearance. Both were prepared by an independent unblinded nurse who took no further part in the study. During injection, the syringe and solution were concealed in an opaque black light-shielding bag, and the clinician who performed the injection did not participate in any subsequent study procedures (block assessment, follow-up, outcome assessment, or data analysis) until unblinding. Participants, outcome assessors, and the statistician remained blinded throughout.

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Written informed consent signed by the patient or authorized legal representative 2. Unilateral intertrochanteric femoral fracture scheduled for closed reduction and PFNA internal fixation under intrathecal (neuraxial) anesthesia 3. Age 65-80 years, either sex 4. American Society of Anesthesiologists (ASA) physical status II-III 5. Body mass index 18-30 kg/m2

Exclusion criteria

* 1\. Known allergy to lidocaine, bupivacaine, or liposomal bupivacaine 2. Trauma or infection at the puncture site, or coagulation disorder 3. Severe cardiac, pulmonary, hepatic, or renal insufficiency, or neurological disease 4. Severe cardiac arrhythmia 5. Long-term use or abuse of analgesic medications 6. Severe preoperative cognitive impairment precluding study assessments 7. History of psychiatric disorders (e.g., depression, anxiety disorder) 8. Pre-existing sleep disorder

Design outcomes

Primary

MeasureTime frameDescription
Leeds Sleep Evaluation Questionnaire (LSEQ) score on the night of admissionNight of admission (within approximately 24 hours after the intervention)Total LSEQ score (10 items, each scored on a 100-mm visual analogue line; total range 0-1000; higher scores indicate better sleep) for the night of admission, i.e., the first night after the study intervention, assessed the following morning by a blinded assessor.

Secondary

MeasureTime frame
LSEQ score on the night of surgeryNight of the day of surgery
LSEQ score on the second postoperative nightPostoperative day 2 (night)
Total sleep time (wristband actigraphy)Objective total sleep time (hours) recorded by a wrist-worn activity tracker (Fitbit Charge 6). Time Frame: Night of admission, night of surgery, and second postoperative night
Deep sleep time (wristband actigraphy)Night of admission, night of surgery, and second postoperative night
Number of nocturnal awakenings (wristband actigraphy)Night of admission, night of surgery, and second postoperative night
Anxiety score (VAS-A)Night of admission, night of surgery, and second postoperative night
Resting pain score (VAS)6, 24, and 48 hours after surgery
Cumulative sufentanil consumption0-48 hours after surgery
Number of effective PCIA demands0-48 hours after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 24, 2026