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

NCT ID: NCT07066111

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2026-12-30

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intramuscularly

The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly.

Group Type: PLACEBO_COMPARATOR

Tramadol

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

bupivacaine liposome (ultrasound-guided high iliofascial space block)

Intervention Type: 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.

Interventions

Tramadol

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hongwei Shi

Director, Department of Anesthesia, Pain and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Liu Han

Role: CONTACT

han_cold.student@sina.com

18951670163

Facility Contacts

YiHong Gao

Role: primary

1023630387@qq.com

18921767282

Other Identifiers

KY 20250527-02

Identifier Type: -

Identifier Source: org_study_id