Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Recruiting

CT.gov ID

NCT05250492

Collaborator

European Clinical Trial Experts Network (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Prosthesis Analgesia PENG Block	Procedure: Prosthetic hip surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery

Actual Study Start Date :

Feb 9, 2022

Anticipated Primary Completion Date :

May 9, 2022

Anticipated Study Completion Date :

Sep 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with PENG block	Procedure: Prosthetic hip surgery 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.
Active Comparator: Patients with intra-articular infiltration	Procedure: Prosthetic hip surgery 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.

Arm

Intervention/Treatment

Experimental: Patients with PENG block

Procedure: Prosthetic hip surgery

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.

Active Comparator: Patients with intra-articular infiltration

Procedure: Prosthetic hip surgery

Outcome Measures

Primary Outcome Measures

Total amount of morphine (mg) [45 days]
total amount of morphine administered intraoperatively, in milligrams.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean-François Oudet	Lanester		France	56600

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05250492

Other Study ID Numbers:

2021-A00539-32

First Posted:

Feb 22, 2022

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Feb 22, 2022