Back to resultsUltrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
lumbar plexus block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing orthopedic trauma operations of the lower extremeties
- Age >70 years old
Exclusion Criteria:
- Preexisting neuropathy of Lumbar plexus
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Allergy to local anaesthetics
- Prior surgery at the lumbar region
Sites / Locations
- Attikon Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Modified Shamrock approach
Arm Description
Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.
Outcomes
Primary Outcome Measures
Time required to localize the lumbar plexus
The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus)
Complications from lumbar plexus blockade
Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.)
Secondary Outcome Measures
Postoperative pain
Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score <4 is considered adequate.
Full Information
NCT ID
NCT04346758
First Posted
November 21, 2019
Last Updated
December 6, 2020
Sponsor
Attikon Hospital
Collaborators
University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04346758
Brief Title
Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
Official Title
Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
Collaborators
University of Athens
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
A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.
Detailed Description
A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Shamrock approach
Arm Type
Other
Arm Description
Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.
Intervention Type
Procedure
Intervention Name(s)
lumbar plexus block
Intervention Description
Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.
Primary Outcome Measure Information:
Title
Time required to localize the lumbar plexus
Description
The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus)
Time Frame
10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus)
Title
Complications from lumbar plexus blockade
Description
Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score <4 is considered adequate.
Time Frame
4 hours (visual analogue scale 0-10 at 4 hours postoperatively)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing orthopedic trauma operations of the lower extremeties
Age >70 years old
Exclusion Criteria:
Preexisting neuropathy of Lumbar plexus
Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
Allergy to local anaesthetics
Prior surgery at the lumbar region
Facility Information:
Facility Name
Attikon Hospital
City
Athens
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.
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