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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06062134
Other study ID # 2023-146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2023
Est. completion date December 21, 2023

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 21, 2023
Est. primary completion date December 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. an indication for PENG blocks for postoperative pain management 2. American Society of Anesthesiologists (ASA) physical status I or II 3. at least 18 years old, and able to understand the purpose and risks of the study Exclusion Criteria: 1. pregnancy 2. body mass index above 35 kg/m2 3. hepatic or renal insufficiency 4. history of allergic or adverse reactions to local anesthetics or contrast agents.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pericapsular nerve group block
Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
Drug:
18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
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)

Locations

Country Name City State
Belgium Clinique Ste Anne-St Remi Brussels

Sponsors (1)

Lead Sponsor Collaborator
Philippe Gauthier

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint Computed tomography images will be used as measurement tool 2 hours
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