Postoperative Delirium
Conditions
Keywords
preemptive analgesia, bupivacaine liposome, ip fracture surgery, postoperative delirium
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.
Interventions
DRUGTramadol
The control group routinely injected tramadol 100mg(Tramal) intramuscularly
DRUGbupivacaine 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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | twice a day for 1-3 days after the operation | Evaluate rest and exercise pain via VAS score (0-10). |
| 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. |
| Anesthesia method form | during operation | Anesthesia method of the surgery |
| 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. |
| postoperative complications | Periprocedural | postoperative complications after the surgery |
| length of hospital stay | Periprocedural | length of hospital stay |
| 30-day mortality | 30-day after surgery | 30-day mortality |
| intraoperative medication checklist | during operation | intraoperative medication of the surgery |
Countries
China
Contacts
Primary ContactLiu Han
Outcome results
None listed