Back to resultsEvaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API) (API)
Primary Purpose
Hip Prosthesis, Analgesia, PENG Block
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prosthetic hip surgery
Sponsored by
About this trial
This is an interventional prevention trial for Hip Prosthesis
Eligibility Criteria
Inclusion Criteria:
- Patient, male or female, over 18 years old.
- Patient scheduled for anterior hip prosthesis.
- Affiliated patient or beneficiary of a social security scheme.
- Patient having been informed and having signed a free and informed consent.
Exclusion Criteria:
- Patient with a contraindication to local anesthesia.
- Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
- Patient participating in another clinical study.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
- Pregnant, breastfeeding or parturient woman.
- Patient hospitalized without consent.
Sites / Locations
- Jean-François OudetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with PENG block
Patients with intra-articular infiltration
Arm Description
Outcomes
Primary Outcome Measures
Total amount of morphine (mg)
total amount of morphine administered intraoperatively, in milligrams.
Secondary Outcome Measures
Full Information
NCT ID
NCT05250492
First Posted
February 10, 2022
Last Updated
February 10, 2022
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05250492
Brief Title
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)
Acronym
API
Official Title
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
May 9, 2022 (Anticipated)
Study Completion Date
September 9, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Prosthesis, Analgesia, PENG Block
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with PENG block
Arm Type
Experimental
Arm Title
Patients with intra-articular infiltration
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Prosthetic hip surgery
Intervention Description
Total hip prosthesis performed by an anterior approach with intra-articular infiltration of an anesthetic product intraoperatively.
OR
- Total hip prosthesis performed by an anterior approach with infiltration of the same anesthetic product by ultrasound-guided PENG block intraoperatively.
Primary Outcome Measure Information:
Title
Total amount of morphine (mg)
Description
total amount of morphine administered intraoperatively, in milligrams.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient, male or female, over 18 years old.
Patient scheduled for anterior hip prosthesis.
Affiliated patient or beneficiary of a social security scheme.
Patient having been informed and having signed a free and informed consent.
Exclusion Criteria:
Patient with a contraindication to local anesthesia.
Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
Patient participating in another clinical study.
Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Pregnant, breastfeeding or parturient woman.
Patient hospitalized without consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Jean-François Oudet
City
Lanester
ZIP/Postal Code
56600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Oudet, Dr
Phone
0683346567
Email
jf.oudet@ecten.eu
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)
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