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

NCT05250492 | Completed

• 1 other identifier: 2021-A00539-32
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.

Conditions

Hip Prosthesis; Analgesia; PENG Block

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption in the postoperative care unit

  Postoperative morphine consumption (in mg) in the postoperative care unit

  1 hour

Secondary Outcomes (1)

• Postoperative morphine équivalent consumption at postoperative day 1

  1 day

Study Arms (2)

Patients with PENG block

EXPERIMENTAL

Procedure: Prosthetic hip surgery

Patients with intra-articular infiltration

ACTIVE COMPARATOR

Procedure: Prosthetic hip surgery

Interventions

Prosthetic hip surgery 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 PENG block; Patients with intra-articular infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Jean-François Oudet

Lanester, 56600, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: March 2, 2022
• Primary Completion: September 9, 2022
• Study Completion: May 15, 2023
• Last Updated: December 6, 2024

Record last verified: 2022-02

Locations

FR (1)