Postoperative DeliriumPhase 4NCT07066111
The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery
A Phase 4 study testing Tramadol and bupivacaine liposome (ultrasound-guided high iliofascial space block) in people with Postoperative Delirium, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Tramadol and bupivacaine liposome (ultrasound-guided high iliofascial space block)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospital
Nanjing, Jiangsu, 210006
YiHong Gao, 18921767282, 1023630387@qq.com
About this study
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
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.
Read the 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
- Being tested
- Tramadol, bupivacaine liposome (ultrasound-guided high iliofascial space block)
- Keywords
- preemptive analgesia, bupivacaine liposome, ip fracture surgery, postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| intramuscularly | Placebo comparator | The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly. Receives: Drug: Tramadol |
| ultrasound-guided high iliofascial space block | Experimental | The elderly patients with hip fractures who were randomly divided into the experimental group were given ultrasound-guided high iliofascial space block Receives: Drug: bupivacaine liposome (ultrasound-guided high iliofascial space block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
POD incidence
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.
Measured: Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)
Secondary outcomes (10)
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.
Measured: before the surgery.
Postoperative pain
Evaluate rest and exercise pain via VAS score (0-10).
Measured: 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.
Measured: 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.
Measured: 24 hours after surgery
Anesthesia method form
Anesthesia method of the surgery
Measured: during operation
intraoperative medication checklist
intraoperative medication of the surgery
Measured: 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.
Measured: during the operation
postoperative complications
postoperative complications after the surgery
Measured: Periprocedural
length of hospital stay
length of hospital stay
Measured: Periprocedural
30-day mortality
30-day mortality
Measured: 30-day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Shi, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066111
- Sponsor's protocol ID
- KY 20250527-02
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07066111
- Acronym / sponsor ID
- KY 20250527-02
- Conditions
- Postoperative Delirium
- Keywords
- preemptive analgesia, bupivacaine liposome, ip fracture surgery, postoperative delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intramuscularly | Placebo comparator | Drug: TramadolThe elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly. |
| ultrasound-guided high iliofascial space block | Experimental | Drug: bupivacaine liposome (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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolThe control group routinely injected tramadol 100mg(Tramal) intramuscularly | Drug | intramuscularly |
| 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. | Drug | ultrasound-guided high iliofascial space block |
Primary outcome
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: 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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol and bupivacaine liposome (ultrasound-guided high iliofascial space block) in people with Postoperative Delirium, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Han (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POD incidence (time frame: Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.