A Phase 4 interventional study of Tramadol and bupivacaine liposome (ultrasound-guided high iliofascial space block) in Postoperative Delirium, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Phase 4, Interventional, and Treatment
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.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly.
Drug: Tramadol
The elderly patients with hip fractures who were randomly divided into the experimental group were given ultrasound-guided high iliofascial space block
Drug: bupivacaine liposome (ultrasound-guided high iliofascial space block)
The control group routinely injected tramadol 100mg(Tramal) intramuscularly
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.
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)
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
Anesthesia method form
Anesthesia method of the surgery
Time frame: during operation
intraoperative medication checklist
intraoperative medication of the surgery
Time frame: during operation
Number of participants with hemodynamic changes
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.
Time frame: during the operation
postoperative complications
postoperative complications after the surgery
Time frame: Periprocedural
length of hospital stay
length of hospital stay
Time frame: Periprocedural
30-day mortality
30-day mortality
Time frame: 30-day after surgery
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Nanjing First Hospital, Nanjing Medical University