Clinical trial NCT05673486: Regional Anesthesia by PENG-Block in Emergency Department
Official title: Analgesic Efficacy of Regional Anesthesia by PENG-Block in Patients Diagnosed With Hip Fractures in the Emergency Department: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Regional anesthesia
PENG block
Morphine consumption
Opioid sparing
Multimodal analgesia
Femoral neck fracture, intertrochanteric region fracture
Emergency department
Emergency medicine physician
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2023-01-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is a single-centre, open-label randomized comparative trial. Adult patients admitted to the emergency department for a hip fracture will be enrolled.

Pericapsular nerve block (PENG-block) is a regional anesthesia technique developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. Some authors propose the use of PENG-Block as an alternative to fascia iliaca block and femoral block for the analgesic management of hip fracture in the emergency department, but scientific evidence is weak in this setting.

The hypothesis of this study is that the use of PENG Block in the emergency department provides a better pain management for patients suffering from hip fractures with less opioid use.

Detailed description: Pericapsular nerve block (PENG-block) is a regional anesthesia technique first described in 2018 and developed primarily as an analgesic technique in a perioperative setting during hip fractures related surgical procedures. The analgesic treatment with PENG-Block prevents motor block and thus reduces risk of intra-hospital falls. It also allows patients to get back on their feet more quickly and thus reduces loss of autonomy and risk of dependency. Moreover, it is a technique with a good safety profile that appears to be appropriate, feasible and effective in the context of the analgesic management of hip fractures in the emergency department. Therefore, some authors propose the use of PENG Block as an alternative to fascia iliaca block and femoral block for the analgesic management of this type of fracture.

The main objective of this study is to evaluate the effect of PENG Block combined with conventional multimodal analgesia when compared with conventional multimodal analgesia alone in terms of reduction of total morphine consumption in patients admitted to the emergency department for a hip fracture. The primary endpoint is the total morphine consumption from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours. The secondary objectives are : to assess whether the use of PENG-Block has an influence on the pain felt by the patient compared to conventional analgesia alone; to describe the tolerance of analgesia in the 2 groups; to assess whether the use of PENG-Block has an influence on the duration of hospitalization in the emergency department compared to conventional analgesia alone.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18 years old) admitted to the emergency department for a hip fracture
2. Pain assessed by VAS/NRS ≥ 3 when the clinical suspicion of hip fracture is confirmed by the emergency physician
3. Patients capable of expressing his/her consent prior to participation in the study
4. Affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

1. Patients for who it is impossible to collect the pain assessment scale
2. Patients with known or suspected bleeding disorders :

   * Personal and family history of bleeding symptoms (spontaneous or induced)
   * Clinical signs suggesting a haemostasis disorder
   * Patient on anticoagulant at a curative dose with a very high risk of bleeding (labile International Normalized Ratio (INR), mechanical valve, acute kidney failure and treatment with direct oral anticoagulants)
   * Inherited bleeding disorder (Hemophilia A, Hemophilia B, Von Willebrand disease, Fibrinogen deficiency, Factor XII deficiency)
   * Pathologies that may interfere with hemostasis: advanced liver disease, decompensated hematological disease, collagen diseases such as Ehlers-Danlos disease
3. Patients in whom it is impossible to perform the PENG-Block: Body Mass Index (BMI) \> 40, adenopathy or infection at the puncture site, allergy to the anesthetics used
4. Pregnant, parturient or breastfeeding women
5. Patients under judicial protection or judicial safeguard
6. Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives

Primary outcomes:
measure: Total morphine consumption
timeFrame: Up to 24 hours after randomization
Secondary outcomes:
measure: Pain intensity according to a Numeric Rating Scale (NRS)
timeFrame: Up to 24 hours after randomization
measure: Presence of side effects
timeFrame: Up to 24 hours after randomization
measure: Duration of hospitalization in the emergency department
timeFrame: Up to 24 hours after randomization
Other outcomes:
Locations:
city: Hyères
country: France
facility: Hyères Hospital
state: Var
Study officials:
affiliation: Centre Hospitalier de Hyères
name: Laurent CAUMON, MD
role: STUDY_DIRECTOR
References: