- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285333
Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture
Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block
Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.
Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.
The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.
Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.
In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tunis, Tunisia, 2010
- Institut Kassab D'Orthopedie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
- Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)
Exclusion Criteria:
- - ASA physical status ≥ 4.
- Impaired cognition or Dementia.
- Multiple fractures.
- Contraindication to regional anesthesia.
- Patient's disapproval.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: fascial iliaca
: A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament.
We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca.
The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca.
Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine
|
ultrasound guided block with 20 mL lidocaine 1.5%
Other Names:
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Experimental: Percapsular nerve group block
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees.
In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed.
A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.
Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine.
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ultrasound guided block with 20 mL lidocaine 1.5%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
positioning pain
Time Frame: up to 30 minutes
|
Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]
|
up to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positioning Rating
Time Frame: up to 40 minutes
|
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
|
up to 40 minutes
|
Imaging time
Time Frame: up to 10 minutes
|
For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon. For the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata. |
up to 10 minutes
|
Puncture time
Time Frame: up to 10 minutes
|
the time that stretches from the introduction of the needle until the end of the injection of local anesthetic
|
up to 10 minutes
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Performance time
Time Frame: up to 10 minutes
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the imaging time + time to puncture.
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up to 10 minutes
|
Number of punctures
Time Frame: up to 10 minutes
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the number of redirection of the needle after removing 2 cm.
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up to 10 minutes
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pain 5 after block
Time Frame: up to 5 minutes
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verbal rating scale (VRS) [0=no pain ; 4=worst pain]
|
up to 5 minutes
|
pain 10 after block
Time Frame: up to 10 minutes
|
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
|
up to 10 minutes
|
pain 15 after block
Time Frame: up to 15 minutes
|
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
|
up to 15 minutes
|
pain 20 after block
Time Frame: up to 20 minutes
|
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
|
up to 20 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: khaireddine Raddaoui, MD, Tunis El Manar University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-IMKO 102/2019
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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