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

March 27, 2022 updated by: Yangtian Shuang, Yangzhou University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Yangzhou, China
        • Recruiting
        • Affiliated Hospital of Yangzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of hip fracture

Aged 65 or above

ASA Ⅰ-Ⅲ

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug group
S-ketamine 0.1mg/kg was injected intravenously during anesthesia induction and esmolamine 0.1mg/ (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.
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.
Other Names:
  • control group
Experimental: Device group
The hip fracture was diagnosed clinically on admission and ultrasound-guided iliofascial space block was performed after evaluation, and the analgesia lasted 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.
Other Names:
  • control group
Placebo Comparator: Normal saline group
normal saline 0.1ml/kg was injected intravenously during anesthesia induction and normal saline 0.1ml/ (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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of peioperative neurocognitive impairment
Time Frame: Perioperative period
incidence of peioperative neurocognitive impairment
Perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Investigators

  • Study Chair: jJianhong Sun, master, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 26, 2022

Primary Completion (Anticipated)

April 26, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YShuang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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