- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504525
Fascia Iliaca Versus Quadratus Lumborum Block for Pain Management in Total Hip Replacement.
Fascia Iliaca Versus Quadratus Lumborum Block for Postoperative Pain Management in Total Hip Replacement: A Comparative Prospective Randomized Study
Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects.
The investigators aim to compare postoperative pain levels and opioid analgesic needs of fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip arthroplasty under general anesthesia.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11566
- Ain Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients aging between 40-60 years ASA II, III with no known hypersensitivity for local anesthetics
Exclusion Criteria:
- Patient refusal
- Known allergy to local anesthetics
- Previous femoral artery surgery
- Local infection at the site of injection
- Those on anticoagulation therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fascia iliaca block for postoperative pain management in hip arthroplasty
|
Ultrasound guided fascia iliaca block done by palpation of anterior superior iliac spine to identify the inguinal crease, then place the ultrasound probe on it to identify the sartorius muscle.
Sonographic anatomy will be identified, from superficial to deep, consisting of subcutaneous fat, the internal oblique muscle, the transverse abdominis muscle, the fascia iliaca covering the iliacus muscle and the iliacus muscle itself.
The block needle will be advanced in out-of plane to puncture the fascia iliaca.
With the needle tip just below the fascia iliaca, 2 ml of a local anesthetic will be injected to confirm the tip location.
Once the proper position is confirmed, 40 ml of bupivacaine 0.25% will be injected superficial to the iliacus muscle and deep to the fascia iliaca.
|
Active Comparator: Quadratus lumborum block for postoperative pain management in hip arthroplasty
|
The patients will receive anterior ultrasound guided quadratus lumborum block QLB in the lateral position.
The transducer will be first placed in a parasagittal orientation 3-4 cm lateral to the midline and over the sacrum to identify the L5 transverse process.
The probe will then rotated into a transverse orientation with slight medial and caudal angulation to obtain a transverse oblique view at L5 transverse process .The ultrasound probe will be tilted , so the lateral end of the probe will be more cranial than the medial side of the probe to avoid the acoustic shadow of the iliac crest.
Identify the quadratus lumborum and psoas major and inject the local anesthetic above the QL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of postoperative analgesia
Time Frame: 24 hours
|
The investigators will measure the time to first analgesic request after giving the block
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total rescue analgesic requirements
Time Frame: 24 hours
|
Measuring the total rescue analgesic requirement in the postoperative period
|
24 hours
|
Functional recovery
Time Frame: 72 hours
|
Will be assessed by duration of hospital stay
|
72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R118/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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