Post Operative PainNCT06062134
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
A study testing Pericapsular nerve group block and 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast in people with Post Operative Pain and Mechanisms of Analgesia, run by Philippe Gauthier at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Mechanisms of Analgesia
- What is being tested?
- Pericapsular nerve group block and 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- body mass index above 35 kg/m2
- hepatic or renal insufficiency
- history of allergic or adverse reactions to local anesthetics or contrast agents.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post Operative Pain, Mechanisms of Analgesia
- Being tested
- Pericapsular nerve group block, 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group blockProcedure or surgery
Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
18 mL ropivacaine 0.5% + 2 mL radiopaque contrastDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block group | Experimental | 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. Receives: Procedure: Pericapsular nerve group block; Drug: 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint
Computed tomography images will be used as measurement tool
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start18 Oct 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippe Gauthier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Gauthier, Centre Hospitalier Universitaire de Liege
- Investigators
- Philippe Gautier, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062134
- Sponsor's protocol ID
- 2023-146
- Status last verified
- May 2024
- First submitted
- 5 Aug 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balocco AL, Gautier N, Van Boxstael S, Lopez AM, Carella M, Corten K, Sala-Blanch X, Hadzic A, Gautier PE. Pericapsular nerve group block: a 3D CT scan imaging study to determine the spread of injectate. Reg Anesth Pain Med. 2025 Jul 4;50(7):588-591. doi: 10.1136/rapm-2024-105459.
PubMed 38925712
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
- ClinicalTrials.gov ID
- NCT06062134
- Acronym / sponsor ID
- 2023-146
- Conditions
- Post Operative Pain, Mechanisms of Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Philippe GauthierUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block group | Experimental | Procedure: Pericapsular nerve group block, Drug: 18 mL ropivacaine 0.5% + 2 mL radiopaque contrastAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- pregnancy
- body mass index above 35 kg/m2
- hepatic or renal insufficiency
- history of allergic or adverse reactions to local anesthetics or contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericapsular nerve group blockUltrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon. | Procedure or surgery | Pericapsular nerve group block group |
| 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast20 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) | Drug | Pericapsular nerve group block group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 38925712Balocco AL, Gautier N, Van Boxstael S, Lopez AM, Carella M, Corten K, Sala-Blanch X, Hadzic A, Gautier PE. Pericapsular nerve group block: a 3D CT scan imaging study to determine the spread of injectate. Reg Anesth Pain Med. 2025 Jul 4;50(7):588-591. doi: 10.1136/rapm-2024-105459.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gautier principal investigator
Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block and 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast in people with Post Operative Pain and Mechanisms of Analgesia, run by Philippe Gauthier at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of the local anesthetic reaching specific anatomical areas of interest around the hip joint (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.