Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Facia Iliaca block
Anterior Quadratus Lumbroum block
bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- ASA II to IV
- Both sexes
- scheduled for fracture femur surgeries
Exclusion Criteria:
- patients with bleeding disorders and coagulopathy
- infection at the injection site
- known allergy to local anaesthetics
- patients with multiple fractures
- patients with pre-existing myopathy or neuropathy
- patients with significant cognitive dysfunction
- patients who receive long-acting opioids preoperatively
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I: Facia Iliaca block
Group Q: Anterior Quadratus lumbroum block
Arm Description
patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%
Outcomes
Primary Outcome Measures
first request of analgesia
the time the patient felt pain and asked for analgesics
Secondary Outcome Measures
total opioid consumption
total dose of fentanyl used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04709211
Brief Title
Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
Official Title
A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.
Detailed Description
In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I: Facia Iliaca block
Arm Type
Active Comparator
Arm Description
patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%
Arm Title
Group Q: Anterior Quadratus lumbroum block
Arm Type
Active Comparator
Arm Description
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Facia Iliaca block
Intervention Description
patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Anterior Quadratus Lumbroum block
Intervention Description
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
bupivacaine
Primary Outcome Measure Information:
Title
first request of analgesia
Description
the time the patient felt pain and asked for analgesics
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
total opioid consumption
Description
total dose of fentanyl used
Time Frame
48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA II to IV
Both sexes
scheduled for fracture femur surgeries
Exclusion Criteria:
patients with bleeding disorders and coagulopathy
infection at the injection site
known allergy to local anaesthetics
patients with multiple fractures
patients with pre-existing myopathy or neuropathy
patients with significant cognitive dysfunction
patients who receive long-acting opioids preoperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fathy M Tash, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abassia
Country
Egypt
12. IPD Sharing Statement
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Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
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