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

NCT ID: NCT05250492

Last Updated: 2024-12-06

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-05-15

Brief Summary

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The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.

Detailed Description

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Conditions

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Hip Prosthesis Analgesia PENG Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients with PENG block

Group Type EXPERIMENTAL

Prosthetic hip surgery

Intervention Type PROCEDURE

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.

Patients with intra-articular infiltration

Group Type ACTIVE_COMPARATOR

Prosthetic hip surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jean-François Oudet

Lanester, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00539-32

Identifier Type: -

Identifier Source: org_study_id