The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Not Applicable

Not yet recruiting

• Conditions: Postoperative Delirium
• Interventions: Drug: Tramadol; Drug: bupivacaine liposome (ultrasound-guided high iliofascial space block)

• Registration Number: NCT07066111
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

The incidence of hip fractures has risen significantly with population aging. In 2016, the incidence of hip fractures in China was 177 per 100,000 for women and 99 per 100,000 for men, and it is projected that the number of hip fracture surgeries worldwide will reach 6.3 million by 2050. Surgical treatment is preferred among elderly hip fracture patients, but postoperative delirium (POD) is a common complication, with an incidence rate of 4.0%-53.3%, which is much higher than that of elective surgery patients (3.6%-28.3%). POD is closely associated with increased morbidity, mortality and medical expenses, and its mechanism is complex, involving sleep disorders, acute traumatic stress and inflammatory responses.

Elderly people have underlying diseases such as decreased multi-system functions (for example, organ-specific or chronic diseases) and decreased sensory functions (for example, visual and hearing impairments), and hip fractures can cause pain and functional loss. Pain is A Class A risk factor for POD, and about 42 percent of elderly patients with hip fractures experience moderate to severe pain during the acute phase. Pain not only triggers the release of inflammatory factors but also reduces sleep quality, further increasing the risk of POD. Therefore, effective perioperative analgesia is crucial for reducing the incidence of POD.

Regional nerve block analgesia (such as iliofascial block, FIB) has been widely used in recent years because of its definite analgesic effect and few side effects. Bupivacaine liposomes, as a new type of long-acting local anesthetic, can achieve stable drug release within 72 hours after injection and provide long-acting analgesia, but its effect on POD is not yet clear. This study aims to explore the effect of bupivacaine liposomes on preemptive analgesia of iliofascial block on postoperative pain and POD in elderly patients with hip fractures.

Study Timeline

• Study First Submitted: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-20
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intramuscularly	Tramadol	The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly.
ultrasound-guided high iliofascial space block	bupivacaine liposome (ultrasound-guided high iliofascial space block)	The elderly patients with hip fractures who were randomly divided into the experimental group were given ultrasound-guided high iliofascial space block

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Preoperative pain	before the surgery.	Evaluate rest and exercise pain via VAS score (0-10)and record the consumption of analgesics.The higher the VAS score, the more severe the pain will be.
Number of participants with hemodynamic changes	during the operation	hemodynamic changes during the operation.The changes in blood pressure, heart rate, blood oxygen saturation,body temperature and EtCO2 of the patients during the surgery were recorded through the monitoring equipment provided by Mindray.
30-day mortality	30-day after surgery	30-day mortality
Postoperative pain	twice a day for 1-3 days after the operation	Evaluate rest and exercise pain via VAS score (0-10).
Anesthesia method form	during operation	Anesthesia method of the surgery
Number of participants with Sleep quality	from hospitalization to 3 days after surgery(22:30-06:30).	Sleep quality monitored by Cardiopulmonary coupling instrument.The cardiopulmonary coupling (CPC) technology utilizes heart rate variability to measure the function of the autonomic nervous system, and combines it with the extracted respiratory signals from the electrocardiogram (ECG) to generate a sleep profile. Using the CPC device, data such as single-lead ECG signals, sleep duration, respiratory events, activity level, and body position of the patients during sleep are monitored for data analysis to evaluate their sleep conditions.
Recovery quality	24 hours after surgery	Evaluated by QoR-15 score.QoR-15 was used to assess five aspects of postoperative recovery quality (physical comfort, physical independence, psychological support, emotion and pain), with higher scores indicating the higher postoperative recovery quality. The lowest score is 0 points, and the highest score is 150 points.
intraoperative medication checklist	during operation	intraoperative medication of the surgery
postoperative complications	Periprocedural	postoperative complications after the surgery
length of hospital stay	Periprocedural	length of hospital stay

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China