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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthrosis; Hip Arthropathy
• Intervention / Treatment: Procedure: Surgical infiltration; Procedure: PENG Block ultrasound-guided

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 Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime RIFFAULT; Phone Number: 0033 06 79 63 29 55; Email: mriffault@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Damien JOLLY
    • Contact: Maxime RIFFAULT; Phone Number: 0033 06 79 63 29 55; Email: mriffault@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical infiltration	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.
Experimental: PENG Block ultrasound-guided	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption	At 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	Numeric pain intensity scale	At 1 hour postoperative
Pain evaluation	Numeric pain intensity scale	At 2 hours postoperative
Pain evaluation	Numeric pain intensity scale	At 6 hours postoperative
Pain evaluation	Numeric pain intensity scale	At 12 hours postoperative
Pain evaluation	Numeric pain intensity scale	At 24 hours postoperative
Pain evaluation	Numeric pain intensity scale	At 36 hours postoperative
Pain evaluation	Numeric pain intensity scale	At 48 hours postoperative
Success or failure at first stand up test		At 4 hours postoperative
Need for analgesia rescue technique		At 24 hours postoperative
10 meters walk test		At 24 hours postoperative
Muscle strength test		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
Adverse events due to PENG block ou surgical infiltration		At 24 hours postoperative

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Analgesia; Hip; PENG; infiltration; locoregional anesthesia
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: PO24003

Drug and device information, study documents

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