Clinical trial
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
Name
2023-146
Description
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.
Trial arms
Trial start
2023-10-18
Estimated PCD
2023-12-21
Trial end
2023-12-21
Status
Completed
Treatment
Pericapsular nerve group block
Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
Arms:
Pericapsular nerve group block group
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)
Arms:
Pericapsular nerve group block group
Size
10
Primary endpoint
Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint
2 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects enrolled in the study received the same interventional regional analgesia technique (the pericapsular nerve group block) as part of the standard multimodal analgesia protocol. The local anesthetic was mixed with a radiocontrast agent in order to evaluate the spread of the injectate by using CT scan imaging.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking was required for this study.'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-05-29
1 organization
1 product
2 indications
Organization
Philippe GauthierIndication
Postoperative PainIndication
Analgesia