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

Phase 4Not Yet RecruitingNCT07066111

Nanjing First Hospital, Nanjing Medical University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postoperative Delirium

Interventions

TramadolDRUG

The control group routinely injected tramadol 100mg(Tramal) intramuscularly

bupivacaine liposome (ultrasound-guided high iliofascial space block)DRUG

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

POD incidence

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.

Time frame: Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)

Secondary Outcomes

Preoperative pain

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.

Time frame: before the surgery.

Postoperative pain

Evaluate rest and exercise pain via VAS score (0-10).

Time frame: twice a day for 1-3 days after the operation

Number of participants with Sleep quality

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.

Time frame: from hospitalization to 3 days after surgery(22:30-06:30).

Recovery quality

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.

Time frame: 24 hours after surgery

Central Contacts

Liu Han

CONTACT

18951670163 han_cold.student@sina.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.