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Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan

Primary Purpose

Post Operative Pain, Mechanisms of Analgesia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pericapsular nerve group block
18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
Sponsored by
Philippe Gauthier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Ste Anne-St Remi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pericapsular nerve group block group

Arm Description

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.

Outcomes

Primary Outcome Measures

Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint
Computed tomography images will be used as measurement tool

Secondary Outcome Measures

Full Information

First Posted
August 5, 2023
Last Updated
October 2, 2023
Sponsor
Philippe Gauthier
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1. Study Identification

Unique Protocol Identification Number
NCT06062134
Brief Title
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
Official Title
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philippe Gauthier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Mechanisms of Analgesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No masking was required for this study.
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular nerve group block group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Intervention Description
Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
Intervention Type
Drug
Intervention Name(s)
18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
Intervention Description
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)
Primary Outcome Measure Information:
Title
Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint
Description
Computed tomography images will be used as measurement tool
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gautier
Organizational Affiliation
Anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Ste Anne-St Remi
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

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Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan

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