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NCT Number: NCT07066111

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

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.

Primary outcomes

  1. POD incidence

    Time frame: 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:
    • Acute onset of mental changes and fluctuating course of the disease.
    • Inattentiveness.
    • Disordered thinking.
    • Changes in consciousness levels.
    • A POD is diagnosed if it meets 1+2 or 1+3 or 1+4.

Secondary outcomes

  1. Preoperative pain

    Time frame: 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.

  2. Postoperative pain

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

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

  3. Number of participants with Sleep quality

    Time frame: 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.

  4. Recovery quality

    Time frame: 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.

  5. Anesthesia method form

    Time frame: during operation

    Anesthesia method of the surgery

  6. intraoperative medication checklist

    Time frame: during operation

    intraoperative medication of the surgery

  7. Number of participants with hemodynamic changes

    Time frame: 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.

  8. postoperative complications

    Time frame: Periprocedural

    postoperative complications after the surgery

  9. length of hospital stay

    Time frame: Periprocedural

    length of hospital stay

  10. 30-day mortality

    Time frame: 30-day after surgery

    30-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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