Blocks for Intertrochanteric Fracture Repair Surgery
Primary Purpose
Intertrochanteric Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
General anesthesia
Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks
Sponsored by
About this trial
This is an interventional treatment trial for Intertrochanteric Fractures focused on measuring intratrochanteric fracture, general anesthesia, femoral nerve block, lateral femoral cutaneous nerve block
Eligibility Criteria
Inclusion Criteria:
- intratrochanteric fracture
- need for surgery
- contraindications for spinal anesthesia
Exclusion Criteria:
- allergy to local anesthetics
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General anesthesia
Regional anesthesia
Arm Description
Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.
Patients will receive femoral and lateral femoral cutaneous nerves block under ultrasonographical guidance before operation.During surgical procedure they will receive deep sedation with propofol.
Outcomes
Primary Outcome Measures
Percentage of patients surviving 30 days after 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.
Percentage of patients suffering from major cardiovascular event during 30 days after 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.
Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.
Secondary Outcome Measures
Pain score after surgery
Patients will be asked about their pain ranks 6 and 24 hours after surgery. The NRS score will be used (0 to 10) where 0 is no pain and 10 is extremely severe pain.
Opioid consumption
Opioid (eg morphine) consumption will be noted
Full Information
NCT ID
NCT04470115
First Posted
July 1, 2020
Last Updated
July 12, 2020
Sponsor
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04470115
Brief Title
Blocks for Intertrochanteric Fracture Repair Surgery
Official Title
Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Fractures
Keywords
intratrochanteric fracture, general anesthesia, femoral nerve block, lateral femoral cutaneous nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.
Arm Title
Regional anesthesia
Arm Type
Experimental
Arm Description
Patients will receive femoral and lateral femoral cutaneous nerves block under ultrasonographical guidance before operation.During surgical procedure they will receive deep sedation with propofol.
Intervention Type
Other
Intervention Name(s)
General anesthesia
Intervention Description
Patients will receive general endotracheal anesthesia with typical drugs used (propofol, fentanyl, sevoflurane). the exact dose of the drug will be on the discretion of anesthesia provider, according to good clinical practice.
Intervention Type
Other
Intervention Name(s)
Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks
Intervention Description
The femoral nerve (FN) is identified with ultrasound. The needle is inserted in-plane, from lateral to medial. We administer 15 to 17ml of local anesthetic (0.5 to 0.75% ropivacaine). After good anesthetic spread on FN we identify lateral femoral cutaneous nerve (LFCN) in its expected location 2-3 cm below inguinal ligament, laterally to sartorius muscle and inject usually 4 to 5 ml of local anesthetic. Oxygen 2-3 l/min is given via face mask to maintain Sp02 and the block is followed by sedation. Sedation is achieved with boluses of propofol to enable procedure and maintain patient in comfort. We aim to keep the depth of sedation at Ramsay sedation scale of 4. Whether it is possible we use loud verbal stimulus, if it is not we use gently glabella tap to assess depth of sedation. Patient is breathing spontaneously during the whole surgery. After surgical field is prepared, surgeon infiltrates expected entry points of intramedullary nail system with 0,5% lidocaine.
Primary Outcome Measure Information:
Title
Percentage of patients surviving 30 days after the surgery.
Description
Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.
Time Frame
30 days from the day of the surgery.
Title
Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.
Description
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.
Time Frame
30 days from the day of the surgery.
Title
Percentage of patients suffering from postoperative delirium during 7 days after the surgery.
Description
Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.
Time Frame
7 days after the surgery.
Secondary Outcome Measure Information:
Title
Pain score after surgery
Description
Patients will be asked about their pain ranks 6 and 24 hours after surgery. The NRS score will be used (0 to 10) where 0 is no pain and 10 is extremely severe pain.
Time Frame
first 24 hours after surgery
Title
Opioid consumption
Description
Opioid (eg morphine) consumption will be noted
Time Frame
first 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intratrochanteric fracture
need for surgery
contraindications for spinal anesthesia
Exclusion Criteria:
allergy to local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakub Klimkiewicz, MD, PhD
Phone
0048261816896
Email
jklimkiewicz@wim.mil.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Mateusz Gutowski, MD
Phone
0048261816896
Email
mgutowski@wim.mil.pl
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Klimkiewicz, MD, PhD
Phone
0048261816896
Email
jklimkiewicz@wim.mil.pl
First Name & Middle Initial & Last Name & Degree
Mateusz Gutowski, MD
Phone
0048261816896
Email
mgutowski@wim.mil.pl
First Name & Middle Initial & Last Name & Degree
Jakub Klimkiewicz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mateusz Gutowski, MD
First Name & Middle Initial & Last Name & Degree
Bartosz Rustecki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dymitr Kochanowski, MD
First Name & Middle Initial & Last Name & Degree
Anna Klimkiewicz, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Blocks for Intertrochanteric Fracture Repair Surgery
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