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

NCT07892859 | Completed

• 1 other identifier: CangzhouH CZX2025-KY086-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Leeds Sleep Evaluation Questionnaire (LSEQ) score on the night of admission

  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.

  Night of admission (within approximately 24 hours after the intervention)

Secondary Outcomes (9)

• LSEQ score on the night of surgery

  Night of the day of surgery

• LSEQ score on the second postoperative night

  Postoperative 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

Study Arms (2)

Experimental: Liposomal bupivacaine group (Group Z)

EXPERIMENTAL

Ultrasound-guided suprainguinal fascia iliaca compartment block with liposomal bupivacaine 133 mg diluted to 40 mL with normal saline, performed immediately after admission/enrollment.

Drug: Liposomal Bupivicaine

Placebo Comparator: Saline group (Group D)

PLACEBO COMPARATOR

Ultrasound-guided suprainguinal fascia iliaca compartment block with 40 mL of 0.9% normal saline, performed immediately after admission/enrollment by the identical technique.

Drug: Saline Solution (NaCl 0,9%)

Interventions

Liposomal Bupivicaine DRUG

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.

Experimental: Liposomal bupivacaine group (Group Z)

Saline Solution (NaCl 0,9%) DRUG

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).

Placebo Comparator: Saline group (Group D)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Li Xiaoyuan: lead

Study Sites (1)

Hebei Province Cangzhou Integrated Chinese and Western Medicine Hospital

Cangzhou, Hebei, 061000, China

Location

MeSH Terms

Conditions

Hip Fractures; Parasomnias; Emergence Delirium; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 10, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CN (1)