- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062134
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
Over the last 20 years, different interventional regional analgesia techniques have been proposed to treat pain after hip surgeries.
The most commonly used techniques are the fascia iliaca and femoral nerve blocks, resulting in reduced pain scores, opioid-sparing effects, and opioid-related adverse effects. However, these interventional analgesia techniques result in a motor block and muscle weakness of the quadriceps muscle, impeding early ambulation and rehabilitation.
Recently, the pericapsular nerve group (PENG) block has been proposed as an effective choice for analgesia after hip surgeries while sparing the motor function of the lower extremities. The aim of this technique is to inject local anesthetic to target the more distal sensory branches innervating the anterior aspect of the hip joint.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ten patients scheduled for hip surgery were included after Ethical Committee approval and informed consent were obtained.
Preoperatively, patients received an ultrasound-guided pericapsular nerve group block. The injections were performed preoperatively using a Canon US Applio 700 with a linear transducer (14 to 6 MHz), and a 21-gauge, 80 mm stimulating needle (SonoPlex Stim, Pajunk ® ️ GmbH, Germany). After confirmation of the correct needle tip position with 2 mL of sodium chloride 0.9%, 20 mL of injectate containing 18 mL ropivacaine 0.5% with 2 mL of radiopaque contrast (Iomeron 300: 61.24% w/v of Iomeprol equivalent to 30% iodine or 300 mg iodine/mL (Bracco UK Limited)) was injected.
After surgery, high-definition CT scans (Siemens) were obtained to determine the distribution patterns of the injectates.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1070
- Clinique Ste Anne-St Remi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- an indication for PENG blocks for postoperative pain management
- American Society of Anesthesiologists (ASA) physical status I or II
- at least 18 years old, and able to understand the purpose and risks of the study
Exclusion Criteria:
- pregnancy
- body mass index above 35 kg/m2
- hepatic or renal insufficiency
- history of allergic or adverse reactions to local anesthetics or contrast agents.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pericapsular nerve group block group
All subjects enrolled in the study received a pericapsular nerve group block using a local anesthetic mixed with a contrast agent.
After injection, subjects were transferred to the CT scan to obtain a 3D reconstruction to determine the spread of the injectate.
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Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
Other Names:
20 mL of injectate: 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast (Iomeron 300: 61.24% w/v of iomeprol equivalent to 30% iodine or 300 mg iodine/mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint
Time Frame: 2 hours
|
Computed tomography images will be used as measurement tool
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Gautier, Anesthesiologist
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-146
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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