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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Hip Prosthesis; PENG Block
• Intervention / Treatment: Procedure: Prosthetic hip surgery

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lanester, France, 56600
    • Jean-François Oudet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption in the postoperative care unit	Postoperative morphine consumption (in mg) in the postoperative care unit	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine équivalent consumption at postoperative day 1	postoperative morphine équivalent consumption (in mg) at postoperative day 1	1 day

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 2021-A00539-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No