- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04709211
Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
August 4, 2022 updated by: Rania Maher Hussien, MD, Ain Shams University
A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
128
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 Locations
-
-
Abassia
-
Cairo, Abassia, Egypt
- Ain Shams University
-
-
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
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I: Facia Iliaca block
patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%
|
bupivacaine
patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%
|
Active Comparator: Group Q: Anterior Quadratus lumbroum block
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%
|
bupivacaine
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
first request of analgesia
Time Frame: 48 hours postoperative
|
the time the patient felt pain and asked for analgesics
|
48 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total opioid consumption
Time Frame: 48 hours postoperative
|
total dose of fentanyl used
|
48 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fathy M Tash, MD, Ain Shams 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 (Actual)
January 10, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
January 7, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 4, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU M D 260/2020
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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