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

Not Applicable

Recruiting

• Conditions: Hip Arthropathy; Hip Arthrosis
• Interventions: Procedure: PENG Block ultrasound-guided; Procedure: Surgical infiltration

• Registration Number: NCT06257160
• Lead Sponsor: CHU de Reims

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-13
• Status Verified: 2024-05
• Study Start: 2024-05-22
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-05-22
• Study Completion: 2026-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG Block ultrasound-guided	PENG Block ultrasound-guided	-
Surgical infiltration	Surgical infiltration	-

Primary Outcome Measures

Name	Time	Method
Morphine consumption	At 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
Need for analgesia rescue technique	At 24 hours postoperative
10 meters walk test	At 24 hours postoperative
Muscle strength test	At 24 hours postoperative
Pain evaluation	At 48 hours postoperative	Numeric pain intensity scale
Success or failure at first stand up test	At 4 hours postoperative
Adverse events due to PENG block ou surgical infiltration	At 24 hours postoperative
Length of hospital stay	At the end of the stay
Adverse events due to consumption of morphine	At 24 hours postoperative

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France