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

NCT ID: NCT06062134

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2023-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Pain Mechanisms of Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

No masking was required for this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pericapsular nerve group block

Intervention Type PROCEDURE

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 contrast

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pericapsular nerve group block

Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.

Intervention Type PROCEDURE

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)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philippe Gauthier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Philippe Gauthier

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Gautier

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique Ste Anne-St Remi

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38925712 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-146

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PENG Block for Total Hip Arthroplasty
NCT05944380 COMPLETED PHASE4