Effects of different anesthesia techniques on cognitive function in elderly hip fracture patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the impact of various enhanced anesthesia techniques on perioperative neurocognitive function in elderly patients undergoing hip fracture surgery. It is a pragmatic, multi-arm, adaptive, open-label, multicenter randomized controlled platform trial comparing these techniques to standard anesthesia care. The interventions include nerve block combined with standard anesthesia, intravenous lidocaine with standard anesthesia, bupivacaine liposome, and ultrasound-guided nerve block. The goal is to determine which anesthesia method best preserves cognitive function in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 65 years and older.
2. Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
3. American Society of Anesthesiologists (ASA) physical status IV or below.
4. The patients or family members provide written informed consent.
5. Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Exclusion Criteria:

1. Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);
2. Two or more anesthetic surgeries are required.
3. Patients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
4. Patients who the researcher believes are unable to complete the assessment of primary outcome;
5. Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Additional exclusion criteria for the nerve block randomization:

1. Contraindications to nerve block, including allergy to local anesthetics, other contraindications specified in the applicable prescribing information, infection at the puncture site, or refusal to receive nerve block;
2. The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction;
3. Receipt of nerve block before randomization during the current hospitalization.

Additional exclusion criteria for the intravenous lidocaine randomization:

1. Allergy to lidocaine;
2. Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment.

Eligibility Criteria for nonsurgical cognitive control participants:

A nonsurgical cognitive control cohort may be recruited from emergency departments, outpatient clinics, inpatient wards, or the community for standardization of neurocognitive assessments. These participants will be matched as far as possible to surgical participants by age and education level. Except for criteria related to hip fracture surgery and trial interventions, the same general inclusion and exclusion criteria will apply. Nonsurgical cognitive control participants must not undergo surgery or anesthesia during the observation period; participants who undergo surgery during follow-up will be excluded from the nonsurgical cognitive control cohort.

Where it's running

• Jinhua Municipal Central Hospital
  Jinhua, Zhejiang, China Recruiting
• Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University
  Lishui, Zhejiang, China Recruiting
• Lishui People's Hospital
  Lishui, Zhejiang, China Recruiting
• Ningbo No.2 Hospital
  Ningbo, Zhejiang, China Recruiting
• Ningbo No.6 Hospital
  Ningbo, Zhejiang, China Recruiting
• Quzhou People's Hospital
  Quzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ting Li, MD, PhD — Second Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Ting Li, MD, PhD
• Email: liting1021@aliyun.com
• Phone: 13587876896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.