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

Analgesia Clinical Trial

— API  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250492
• Other study ID #: 2021-A00539-32
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: February 2022
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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.

Locations

Country	Name	City	State
France	Jean-François Oudet	Lanester

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of morphine (mg)	total amount of morphine administered intraoperatively, in milligrams.	45 days