- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896591
Deep Posterior Post Gluteal Compartment Block in Total Hip Arthroplasty: Feasability and Safety (ANATH)
March 19, 2025 updated by: Yoann ELMALEH, Quincy Anesthésie
Effets D'un Bloc Glutéal Postérieur Profond Associé À Un PENG Bloc Dans La Prothèse Totale De Hanche
This study aims to evaluate the effectiveness of a posterior hip capsule block performed in addition to a PENG (Pericapsular Nerve Group) block for patients undergoing hip arthroplasty.
The primary objective is to assess whether this combined approach provides enhanced perioperative analgesia compared to the standard analgesic protocol or the PENG block alone.
Secondary outcomes will focus on opioid consumption, functional recovery, and any potential complications.
By targeting both the anterior and posterior innervation pathways around the hip joint, this combined technique could improve patient comfort, decrease opioid requirements, and potentially expedite rehabilitation after hip arthroplasty.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YOANN ELMALEH, M.D
- Phone Number: +33781330431
- Email: Yoyo.elmaleh@hotmail.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
All adults with total hip arthroplasty
-
Exclusion Criteria:
- Contraindication to regional anesthesia
- allergy
- refusal of the injection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DPPG compartment block
Deep posterior post gluteal compartment block with different volume of product 5,10 and 15 ml (local anesthetics such as naropeine 0.35%) to compare the efficiency of the block without sciatic nerve block effect
|
One injection with ultrasound guidance injection of 5, 10 or 15 mL of naropeine 0.35 % Procedure : injection below the piriformis muscle in front of the head of the femur.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sciatic nerve block
Time Frame: From enrollment to the end of treatment at 1 month
|
number of patients with postoperative sciatic motor or sensitory nerve block collected by clinical examination (test with hot and cold in the sciatic territory and motricity of the feet)
|
From enrollment to the end of treatment at 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain postoperative
Time Frame: From enrollment to the end of treatment at 1 MONTH
|
Visual analogic pain (VAS) AT 6 hours 0 : no pain 10: maximum pain
|
From enrollment to the end of treatment at 1 MONTH
|
|
pain 2
Time Frame: From enrollment to the end of treatment at 1 MONTH
|
Visual analogic pain (VAS) AT 12 hours 0 : no pain 10: maximum pain
|
From enrollment to the end of treatment at 1 MONTH
|
|
oPIOID Consumption
Time Frame: From enrollment to the end of treatment at 7 months
|
Opioid consumption per and postoperative until 48 hours
|
From enrollment to the end of treatment at 7 months
|
|
RAAC
Time Frame: From enrollment to the end of treatment at 1 MONTH
|
QOR15 scale at H24 and H48 questionnaire with 15 questions from 0 to 10 (https://pqip.org.uk/FilesUploaded/Myles%20QoR-15.pdf)
|
From enrollment to the end of treatment at 1 MONTH
|
|
Surgical complication
Time Frame: From enrollment to the end of treatment at 1 MONTH
|
Surgical postoperative complication or fall
|
From enrollment to the end of treatment at 1 MONTH
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: yoann ELMALEH, M.D, Hôpital Privé Claude Galien
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
March 13, 2025
First Submitted That Met QC Criteria
March 19, 2025
First Posted (Estimated)
March 26, 2025
Study Record Updates
Last Update Posted (Estimated)
March 26, 2025
Last Update Submitted That Met QC Criteria
March 19, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- COS-RGDS-2024-06-039-P-ELMALEH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Arthroplasty
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
Ortho Development CorporationOregon Health and Science UniversityEnrolling by invitationTotal Hip Replacement | Total Hip ArthroplastyUnited States
-
National Taiwan University HospitalUnknownTotal Hip Replacement | Total Hip ArthroplastyTaiwan
-
The Affiliated Hospital Of Southwest Medical UniversityCompletedTotal Knee Arthroplasty | Total Hip Arthroplasty | ERASChina
-
Bispebjerg HospitalNot yet recruitingTotal Hip Arthroplasty (THA) | Revision Hip Arthroplasty
-
James A. KeeneyCompletedPrimary Total Hip Arthroplasty | Primary Total Knee ArthroplastyUnited States
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Rush University Medical CenterRecruitingAnterior Cruciate Ligament Reconstruction | Total Knee Arthroplasty | Hip Arthroscopy | Total Hip Arthroplasty (THA)United States
Clinical Trials on Deep posterior post gluteal nerve block
-
Kirsehir Ahi Evran UniversitesiNot yet recruitingPostoperative Pain | Total Hip Arthroplasty (THA)
-
Samsun UniversityCompletedHip Surgery | Acute Pain ManagementTurkey (Türkiye)
-
Ain Shams UniversityNot yet recruitingPostoperative Pain | Hip Fractures | Hip OsteoarthritisEgypt
-
Bagcilar Training and Research HospitalCompleted
-
Tanta UniversityCompletedAnalgesia | Suprascapular Nerve Block | Shoulder Arthroscopic Surgery | Axillary Nerve Block | Serratus Posterior Superior Intercostal Plane BlockEgypt
-
Second Affiliated Hospital of Wenzhou Medical UniversityCompleted
-
Cumhuriyet UniversityCompletedShoulder Arthroscopic Surgery | Pain After Shoulder SurgeryTurkey (Türkiye)
-
General Hospital of Ningxia Medical UniversityRecruiting
-
Carilion ClinicRecruiting
-
Larissa University HospitalCompletedSurgery | Anterior Cruciate LigamentGreece