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

NCT07066111 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: KY 20250527-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

preemptive analgesia; bupivacaine liposome; ip fracture surgery; postoperative delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)

Secondary Outcomes (10)

• Preoperative pain

  before the surgery.

• Postoperative pain

  twice a day for 1-3 days after the operation

• Number of participants with Sleep quality

  from hospitalization to 3 days after surgery(22:30-06:30).

• Recovery quality

  24 hours after surgery

• Anesthesia method form

  during operation

Study Arms (2)

intramuscularly

PLACEBO COMPARATOR

The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly.

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

Drug: bupivacaine liposome (ultrasound-guided high iliofascial space block)

Interventions

Tramadol DRUG

The control group routinely injected tramadol 100mg(Tramal) intramuscularly

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.

ultrasound-guided high iliofascial space block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Liu Han

CONTACT

18951670163; han_cold.student@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesia, Pain and Perioperative Medicine

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 15, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)