Nanjing First Hospital, Nanjing Medical University
Phase
Phase 4
Started
2025-07-20
Last updated
2025-07-15
Condition(s) studied
Postoperative Delirium
Investigational drug(s) / intervention(s)
Tramadolbupivacaine liposome (ultrasound-guided high iliofascial space block)
Tramadol: The control group routinely injected tramadol 100mg(Tramal) intramuscularly
bupivacaine liposome (ultrasound-guided high iliofascial space block): the experimental group was given ultrasound-guided high iliofascial space block: High-frequency linear probe (5-13 MHZ, Sonosite, USA) was used to identify the iliac bone, iliac muscle and deep circumiliac artery. Then a short oblique puncture needle was used, with the intraplanar technique, and the needle was inserted from the outside. When the needle tip reached the surface of the iliac muscle (iliac fascia space), 20ml of bupivacaine liposome was injected. After the operation, electrocardiogram monitoring(Mindray) was performed for 1 hour to observe adverse reactions.
Study summary
To explore the effects of bupivacaine liposomes in preemptive analgesia for iliofascial block on postoperative pain and postoperative delirium in elderly patients with hip fractures, to optimize perioperative analgesia strategies, to reduce the incidence of postoperative delirium, and to improve patient prognosis.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with hip fractures scheduled for surgical treatment (including femoral neck fractures, intertrochanteric fractures, and fractures more than 5 cm below the lesser trochanter of the femur).
* Age ≥65 years.
* American Society of Anesthesiologists (ASA) grade I - III.
* The patient or family member signed the informed consent form
Exclusion Criteria:
* Compound injuries (such as combined fractures of the head, chest, pelvis, or limbs).
* Have a clear history of mental illness or are taking psychotropic drugs.
* Preoperative delirium or the use of delirium-related medications (such as olanzapine).
* A history of acute cerebrovascular disease (cerebral infarction or cerebral hemorrhage) within 6 months.
* Patients requiring sedation or postoperative coma due to the condition.
* Allergy to amide local anesthetics.
* Severe arrhythmia or liver or kidney dysfunction
Primary outcome measure(s)
POD incidence — Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00) Evaluated via the CAM scale.
* CAM diagnostic criteria:
1. Acute onset of mental changes and fluctuating course of the disease.
2. Inattentiveness.
3. Disordered thinking.
4. Changes in consciousness levels.
* A POD is diagnosed if it meets 1+2 or 1+3 or 1+4.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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