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Clinical Trials/NCT04470115
NCT04470115
Unknown
Not Applicable

Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery

Military Institute od Medicine National Research Institute1 site in 1 country100 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intertrochanteric Fractures
Sponsor
Military Institute od Medicine National Research Institute
Enrollment
100
Locations
1
Primary Endpoint
Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
Last Updated
5 years ago

Overview

Brief Summary

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Detailed Description

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks. Patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. One group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation. Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Military Institute od Medicine National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Jakub Klimkiewicz

Principal Investigator

Military Institute od Medicine National Research Institute

Eligibility Criteria

Inclusion Criteria

  • intratrochanteric fracture
  • need for surgery
  • contraindications for spinal anesthesia

Exclusion Criteria

  • allergy to local anesthetics

Outcomes

Primary Outcomes

Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.

Time Frame: 30 days from the day of the surgery.

Occurence of stroke or acute coronary syndrome will be assessed during period of 30 postoperative days. The result will be displayed as a percentage of examined group.

Percentage of patients suffering from postoperative delirium during 7 days after the surgery.

Time Frame: 7 days after the surgery.

Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.

Percentage of patients surviving 30 days after the surgery.

Time Frame: 30 days from the day of the surgery.

Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.

Secondary Outcomes

  • Opioid consumption(first 24 hours after surgery)
  • Pain score after surgery(first 24 hours after surgery)

Study Sites (1)

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