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Effect of Preoperative Liposomal Bupivacaine Single-Injection Pericapsular Nerve Group Block (PENG) on Lower Extremity Deep Vein Thrombosis in Elderly Patients with Hip Fractures : A Randomized Controlled, Double-Blind, Prospective Clinical Study

The regulatory mechanism of the inflammation (IL-6) - immune thrombosis (NETs) axis in deep vein thrombosis of the lower limbs following hip fractures and the intervention effect of preemptive analgesia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100799
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Hip fracture lower limb deep vein thrombosis

Interventions

Liposomal bupivacaine group:Participants immediately received ultrasound-guided perineural nerve block on the affected side after admission, using 20mL of liposomal bupivacaine (266mg).All patients re
Sham control group:Participants immediately received ultrasound-guided pericapsular nerve group block on the affected side after admission, using 20mL of saline.All patients received intravenous non-s

Sponsors

Shunde Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with hip fractures, including femoral neck fractures and intertrochanteric fractures. 2. Age >= 65 years. 3. 18 kg/m^2 <= BMI <= 30 kg/m^2. 4. American Society of Anesthesiologists classification of I-III. 5. Voluntarily signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Composite injury: Multiple fractures combined, such as trauma in areas other than the hip fracture. 2. Positive ultrasound examination for bilateral lower limb deep vein thrombosis with obstructed forward movement. 3. Contraindications related to LB: History of liposome allergy, history of allergy to local anesthetics (including bupivacaine, ropivacaine, and their derivatives), and severe cardiovascular and respiratory dysfunction. 4. Contraindications related to nerve block: Infection at the puncture site, abnormal nerve function in the lower limbs, and local or systemic infection. 5. Time from injury to hospitalization > 24 hours. 6. Patients with severe liver and kidney dysfunction. 7. Patients with a history of drug addiction or abuse. 8. MMSE score less than 26 points. 9. History of old lower limb deep vein thrombosis. 10. Patients with coagulation dysfunction. 11. Patients taking anticoagulant medications. 12. Patients with an electrocardiogram showing a ventricular rate of less than 50 beats per minute or prolonged Q-T interval. 13. Patients with blood-related diseases or other conditions requiring transfusion. 14. Patients participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Incidence of deep vein thrombosis in both lower extremities;

Secondary

MeasureTime frame
Function-based pain assessment;The situation regarding opioid remedies(The initial analgesic remedial time and total remedial volume).;Perioperative stress levels (IL1, IL6, C-reactive protein, procalcitonin, interferon a),;Perioperative thrombosis-related indicators (MPO-DNA complex, citrulline histone H3, D-dimer);The adverse events related to this study (such as blockade operations, bupivacaine liposome, and opioids, etc.);Preoperative waiting time;Length of hospital stay;Total expenses during hospitalization;

Countries

China

Contacts

Public ContactHaobin Peng

Shunde Hospital of Guangzhou University of Traditional Chinese Medicine

476736369@qq.com+86 188 1871 1784

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026