Clinical Trials Directory

Trials / Completed

CompletedNCT06257160

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
224 (actual)
Sponsor
CHU de Reims · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgical infiltrationDuring 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.
PROCEDUREPENG Block ultrasound-guidedWe 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.

Timeline

Start date
2024-05-22
Primary completion
2025-09-18
Completion
2025-09-18
First posted
2024-02-13
Last updated
2025-12-03

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06257160. Inclusion in this directory is not an endorsement.