The Role of Precision Anesthesia Strategy on Perioperative Organ Protection in Hip Surgery [PASPOP]

NCT06696404 | Completed

• 1 other identifier: 2024-147-（1）
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to investigate the effect of three anesthetic strategies on organ protection in elderly patients undergoing hip fracture surgery. The main questions it aims to answer are: 1.Does the nerve block anesthesia group have a protective effect on the incidence of postoperative delirium in elderly patients undergoing hip surgery? 2.Does the nerve block anesthesia group also provide protective effects on other organs for elderly patients undergoing hip surgery? 3.What effects will these anesthetic strategies have on short-term and long-term prognosis of elderly patients undergoing hip surgery? The investigators will compare it with the spinal anesthesia group and the general anesthesia group to see which has a better protective effect on organs. Participants will undergo preoperative interviews and will be interviewed twice daily, in the morning and evening, from postoperative day 1 to 7 or until discharge, to assess the occurrence of delirium and cognitive levels, pain intensity, and sleep status. Interventions:

1. 1.Nerve block anesthesia group (NA group): Combined Lumbar and Sacral Plexus Block + sedation or laryngeal mask anesthesia
2. 2.General anesthesia group (GA group): General anesthesia (Endotracheal intubation) + iliac fascial block
3. 3.Spinal anesthesia group (SA group): Spinal anesthesia without any nerve blockade

Conditions

Elderly (People Aged 65 or More); Hip Fracture; Delirium - Postoperative; Organ Protection; Nerve Block

Keywords

nerve block; hip fracture; elderly; postoperative delirium; organ protection

Outcome Measures

Primary Outcomes (1)

• Incidence of of postoperative delirium

  Incidence of of postoperative delirium within 7 days or before discharge (whichever comes first) is assessed by 3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM) scale. Each item in the 3D-CAM instrument directly informs one of the 4 CAM features in the algorithm that leads to determining the presence or absence of delirium.The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness. Negative indicates that the paticipant did not experience delirium at the time of assessment, which is favorable for the paticipant. Positive indicates that the participant is experiencing delirium at the time of assessment.

  From enrollment to the seventh day after surgery or before discharge

Secondary Outcomes (10)

• Postoperative pain score

  From enrollment to the third day after surgery

• Consumption of opioid medications

  From the start of surgery to the seventh day after surgery or at discharge

• Central nervous system complications

  From the start of surgery to the thirtieth day after surgery

• Cognitive function

  From enrollment to the thirtieth day after surgery

• Cardiovascular system complications

  From enrollment to the thirtieth day after surgery

Study Arms (3)

NA group

EXPERIMENTAL

Nerve block anesthesia group(NA) Intervention: combined Lumbar Plexus and Sacral Plexus Block, with sedation or laryngeal mask anesthesia (induction with Propofol 1-3mg/kg, Sufentanil 0.1-0.4ug/kg)

Procedure: Combined Lumbar Plexus and Sacral Plexus Block

GA group

ACTIVE COMPARATOR

General anesthesia was performed as an endotracheal intubation combined with iliac fascial block (0.33 ropivacaine 30 ml)

Procedure: iliac fascial block

SA group

ACTIVE COMPARATOR

Spinal anesthesia was performed as a standard care of spinal anesthetic

Procedure: spinal anesthesia

Interventions

Combined Lumbar Plexus and Sacral Plexus Block PROCEDURE

This intervention of Combined Lumbar Plexus and Sacral Plexus Block is assigned to Nerve block anesthesia group (NA group): A combined Lumbar Plexus Block (0.33% Ropivacaine 30ml) and Sacral Plexus Block (0.33% Ropivacaine 20ml) administered as a single injection.

Also known as: Lumbar - Sacral Plexus Block, Lumbosacral Plexus Block, Lumbosacral Plexus Nerve Block, Lumbosacral Regional Nerve Block, Lumbosacral Plexus Regional Block

NA group

iliac fascial block PROCEDURE

iliac fascial block administered as a single injection below the iliac fascial with 0.33% ropivacaine 30ml.

Also known as: iliac fascial compartment block, Fascia Iliaca Block, Fascia Iliaca Nerve Block, Fascia Iliaca Block Technique

GA group

spinal anesthesia PROCEDURE

Spinal anesthesia was performed as a standard care of spinal anesthetic. The spinal puncture site is at L2-3 or L3-4. After the puncture needle reaches the subarachnoid space, 1% ropivacaine 0.8-2 ml, totaling 8-20mg, is injected. Depending on the center's practice, it may be replaced with an equivalent dose of bupivacaine .

Also known as: spinal block, intrathecal anesthesia

SA group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years and older
• American Society of Anesthesiologists (ASA) physical status 1 to 3
• Scheduled for unilateral hip surgery

You may not qualify if:

• Have psychiatric disorders or cognitive impairments, or are unable to understand the scale
• Have a heart failure history (EF \< 40) or a history of AMI in 3 months
• Complex injuries: multiple fractures, chest, abdomen, pelvic and sacral trauma, head trauma, etc.
• Combined with respiratory failure or hepatic failure (Child-Pugh C) or renal failure (rely on dialysis treatment)
• Nerve block contraindication: puncture site infection, peripheral neuropathy, regional anesthetic allergy, etc.
• Contraindications of intraspinal anesthesia: coagulation dysfunction, thrombocytopenia, intraspinal space occupying, infection of puncture site, etc.
• Relative contraindications of general anesthesia: known difficult airway, malignant hyperthermia, etc.
• Enrolled in another randomized clinical trial

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead
• Army Medical Center of PLA: collaborator

Study Sites (2)

Arm Medical Center of PLA

Chongqing, Chongqing Municipality, 400042, China

Location

Shanghai 6th People's hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (20)

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MeSH Terms

Conditions

Hip Fractures; Emergence Delirium

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; 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)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician is blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 1. Nerve block anesthesia group (NA group): Combined Lumbar Plexus(0.33% ropivacaine 30ml)and Sacral Plexus Block(0.33% ropivacaine 20ml) + sedation or laryngeal mask anesthesia 2. General anesthesia group (GA group): General anesthesia (Endotracheal intubation) + iliac fascial block(0.33% ropivacaine 30ml) 3. Spinal anesthesia group (SA group): Spinal anesthesia with ropivacaine 8-20 mg or an equivalent dose of Bupivacaine.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion: March 12, 2025
• Study Completion: April 5, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (2)