Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture

Hip Fractures Clinical Trial

Official title:

Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304559
• Other study ID #: YShuang
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2022
• Source: Yangzhou University
• Contact: Tianshuang Yang, bachelor
• Phone: 18852573527
• Email: yangtianshuang2124[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elderly patients with hip fracture are older and have a high incidence of perioperative complications. the postoperative recovery of elderly patients with hip fracture is affected by hemodynamic instability and pain caused by fracture. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable in elderly patients with hip fracture.Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. It can more effectively reduce the perioperative pain of elderly patients with hip fracture.

Description:

With the advent of the aging society, the incidence of hip fracture in elderly patients is increasing year by year, and the incidence of perioperative neurological cognitive impairment (PND) is increasing year by year. PND refers to postoperative brain dysfunction in patients without mental disorders, including postoperative delirium POD and postoperative cognitive dysfunction POCD. PND is more common in clinic, especially in the elderly. The main feature of PND is the long-term decline and decline of cognitive function after operation. PND not only prolongs the length of stay of patients, interferes with postoperative treatment, but even increases mortality. The pathogenesis of PND is not clear, and it is affected by many factors. Studies have shown that keeping intraoperative blood pressure at baseline to 10% above baseline can significantly reduce the incidence of PND. In addition, pain is also an important factor leading to the occurrence of PND. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable. Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. In this study, a randomized controlled trial was conducted to observe the clinical effects of S-ketamine and ultrasound-guided iliac fascia block combined with general anesthesia in elderly patients with hip fracture, and to evaluate their clinical value.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: January 31, 2023
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of hip fracture

Aged 65 or above

ASA ?-?

No mental and nervous system diseases

No pathological fractures, such as bone tumor, bone tuberculosis, osteomyelitis, etc

No puncture site infection

No hospital stay for more than 48 hours after operation

Exclusion Criteria:

Patients with severe cardiac, hepatic and renal dysfunction before operation

Long-term use of analgesics, sedatives and alcoholism

Patients with respiratory tract management difficulties (modified Ma's score is IV)

Previous neuropsychiatric diseases such as severe cerebrovascular, Alzheimer's disease, epilepsy and Parkinson's disease

Previous history of intracranial surgery or craniocerebral injury

Severe vision, hearing, language impairment or other reasons unable to communicate

Allergic or contraindicated to ropivacaine or non-steroidal anti-inflammatory drugs (NSAID)

Emergency surgery or trauma patients.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• S-Ketamine
S-Ketamine0.1mg/kg was injected intravenously during anesthesia induction and S-Ketamine0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.

Device:
• Continuous iliac fascia space block
After admission, the iliac fascia space block and catheterization were performed under the guidance of ultrasound, and the analgesia was continued until two days after operation.

Drug:
• Normal saline
Normal saline0.1ml/kg was injected intravenously during anesthesia induction and Normal saline0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.Normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.

Locations

Country	Name	City	State
China	Affiliated Hospital of Yangzhou University	Yangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of peioperative neurocognitive impairment	incidence of peioperative neurocognitive impairment	Perioperative period