The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tramadol, bupivacaine liposome (ultrasound-guided high iliofascial space block).
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery: A Randomized, Parallel Controlled Prospective Clinical Study
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.
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.
Interventions
- Drug Tramadol
The control group routinely injected tramadol 100mg(Tramal) intramuscularly - 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, electrocardiogr
Primary outcome measures
- POD incidence [Time frame: Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)]
Secondary outcome measures (10)
- Preoperative pain [Time frame: before the surgery.]
- Postoperative pain [Time frame: twice a day for 1-3 days after the operation]
- Number of participants with Sleep quality [Time frame: from hospitalization to 3 days after surgery(22:30-06:30).]
- Recovery quality [Time frame: 24 hours after surgery]
- Anesthesia method form [Time frame: during operation]
- intraoperative medication checklist [Time frame: during operation]
- Number of participants with hemodynamic changes [Time frame: during the operation]
- postoperative complications [Time frame: Periprocedural]
- length of hospital stay [Time frame: Periprocedural]
- 30-day mortality [Time frame: 30-day after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT07066111 · KY 20250527-02