NCT06062134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

August 5, 2023

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Procedure: Pericapsular nerve group blockDrug: 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast

Interventions

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

Pericapsular nerve group block group

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)

Pericapsular nerve group block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • body mass index above 35 kg/m2
  • hepatic or renal insufficiency
  • history of allergic or adverse reactions to local anesthetics or contrast agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ste Anne-St Remi

Brussels, 1070, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Philippe Gautier

    Anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking was required for this study.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2023

First Posted

October 2, 2023

Study Start

October 18, 2023

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations