Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery

Hip Arthropathy Clinical Trial

— PENGORINF  

Official title:

Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257160
• Other study ID #: PO24003
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: May 22, 2026

Study information

• Verified date: May 2024
• Source: CHU de Reims
• Contact: Maxime RIFFAULT
• Phone: 06 79 63 29 55
• Email: mriffault[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Locoregional analgesia, by reducing the consumption of painkillers, is an effective way of reducing morphine or morphine agonist consumption in this surgery. Furthermore, these techniques fit in perfectly with the objectives of accelerated rehabilitation after surgery. Surgical infiltration is a frequently used and effective analgesic technique. PENG block is a new locoregional anesthesia technique which initial results show promising analgesic efficacy and the absence of loss of strength through motor block.

In February 2022, we carried out a survey of national anesthetic practices in posterior hip arthroplasty, with the help of the SFAR (Société Française d'Anesthésie-Réanimation).

It shows that, despite the lack of plentiful literature on the subject, the PENG block is currently the most frequently performed pre-operative block in hip arthroplasty (PENG block in 39.5% of cases, femoral block in 13% of cases).

The survey also shows that in 41.5% of cases, no block is performed, and only intraoperative surgical infiltration is carried out.

PENG block and surgical infiltration are therefore the two analgesic techniques most frequently used in France today.

It is for these reasons that we feel it is essential to carry out a study comparing these two techniques.

Description:

The aim of this study was to compare the clinical efficacy of these two locoregional analgesia strategies in posterior total hip replacement surgery: ultrasound-guided PENG block and surgical infiltration.

The study is a superiority randomized, double-blind (patient and evaluator will be blinded to the randomization group), single-center trial.

Two groups of patients will be compared: a group of patients benefiting from the echo-guided PENG block strategy, and a group of patients benefiting from intraoperative surgical infiltration.

The type of treatment (PENG block or surgical infiltration) will be randomized. The target population concerns patients scheduled for posterior total hip replacement surgery at Reims University Hospital If the hypothesis of the superior efficacy of echo-guided block PENG is confirmed, our analgesia strategy for total hip replacement surgery will be modified, enabling us to offer the most effective locoregional analgesia technique and thus reduce the morbidity and mortality associated with morphine consumption.

This could have both a medical and an economic impact, by optimizing post-operative monitoring and convalescence for these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: May 22, 2026
• Est. primary completion date: May 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients eligible for posterior total hip replacement surgery at Reims University Hospital

• Patients agreeing to take part in the research and having signed the informed consent form

• Patients of full age

• Patients affiliated to a social security scheme

Exclusion criteria:

• Minor patients

• Patients protected by law

• Pregnant and breast-feeding women

• Patients with allergy to local anesthetics

• Patients with neuropathy

• Patients with an ASA score greater than or equal to 4

• Patients undergoing revision surgery on a total hip prosthesis

• Patients undergoing anterior total hip replacement surgery

• Patients suffering from a femur fracture

• Patients with a contraindication to Peng block.

• Patients refusing one of the proposed techniques.

• Persons deprived of their liberty by judicial or administrative decision.

• Persons under psychiatric care

• Persons unable to express their consent.

Related Conditions & MeSH terms

• Hip Arthropathy
• Hip Arthrosis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Surgical infiltration
During surgery, local anesthetics are injected as follow: in the deep plane and in the subcutaneous territory. Infiltration of the deep plane corresponds to pericotyloid injection, with particular attention to the posterior subcapsular area, the obturator foramen and the psoas muscle. Infiltration of the muscular planes is added, with infiltration of the gluteal and pelvitrochanteric muscles.
• PENG Block ultrasound-guided
We perform the femoral block under ultrasound after anesthesia (general or rachianesthesia). The PENG block is a peripheral diffusion nerve block that specifically targets the articular divisions of the femoral, obturator and accessory obturator nerves. The femoral nerve innervates the four parts of the joint capsule, with inconsistency in the anterior inferomedial part of the capsule. The obturator nerve innervates the inferior part of the anterior face of the capsule. The accessory obturator nerve innervates the medial half of the hip joint capsule in over 50% of cases.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		At 24 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 1 hour postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 2 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 6 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 12 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 24 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 36 hours postoperative
Secondary	Pain evaluation	Numeric pain intensity scale	At 48 hours postoperative
Secondary	Success or failure at first stand up test		At 4 hours postoperative
Secondary	Need for analgesia rescue technique		At 24 hours postoperative
Secondary	10 meters walk test		At 24 hours postoperative
Secondary	Muscle strength test		At 24 hours postoperative
Secondary	Length of hospital stay		At the end of the stay
Secondary	Adverse events due to consumption of morphine		At 24 hours postoperative
Secondary	Adverse events due to PENG block ou surgical infiltration		At 24 hours postoperative