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Regional Anesthesia by PENG-Block in Emergency Department (ED-PENGBLOCK)

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PENG Block
Multimodal analgesia
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Fractures focused on measuring Regional anesthesia, PENG block, Morphine consumption, Opioid sparing, Multimodal analgesia, Femoral neck fracture, intertrochanteric region fracture, Emergency department, Emergency medicine physician

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (≥18 years old) admitted to the emergency department for a hip fracture Pain assessed by VAS/NRS ≥ 3 when the clinical suspicion of hip fracture is confirmed by the emergency physician Patients capable of expressing his/her consent prior to participation in the study Affiliated to or beneficiary of a social security regimen Exclusion Criteria: Patients for who it is impossible to collect the pain assessment scale 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 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 Pregnant, parturient or breastfeeding women Patients under judicial protection or judicial safeguard Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives

Sites / Locations

  • Hyères HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG block + multimodal IV analgesia

Multimodal analgesia alone

Arm Description

PENG block + multimodal IV analgesia (Nefopam, Paracetamol, Morphine)

Multimodal IV analgesia (Nefopam, Paracetamol, Morphine)

Outcomes

Primary Outcome Measures

Total morphine consumption
Total morphine consumption in mg per hour from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours

Secondary Outcome Measures

Pain intensity according to a Numeric Rating Scale (NRS)
The patient's pain will be assessed using a Numeric Rating Scale at the start of care in the emergency department, when the clinical suspicion of hip fracture is confirmed by the emergency doctor, then every hour in the emergency room and every 4 hours in the surgery department for 24 hours or until transfer to the operating room if the surgery takes place before. The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
Presence of side effects
The tolerance of analgesic treatments will be assessed by evaluating the presence or absence of side effects, during the first 24 hours of treatment or until surgery if it takes place before : Side effects related to opioids such as Confusion, Bradypnea, Nausea or vomiting Side effects related to PENG-Block such as Pain at the puncture site, Acute retention of urine, Bleeding Any other adverse effects occurring during the study will be collected.
Duration of hospitalization in the emergency department
Duration of care in hours at the emergency department.

Full Information

First Posted
January 2, 2023
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Fondation Apicil
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1. Study Identification

Unique Protocol Identification Number
NCT05673486
Brief Title
Regional Anesthesia by PENG-Block in Emergency Department
Acronym
ED-PENGBLOCK
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Fondation Apicil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Regional anesthesia, PENG block, Morphine consumption, Opioid sparing, Multimodal analgesia, Femoral neck fracture, intertrochanteric region fracture, Emergency department, Emergency medicine physician

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG block + multimodal IV analgesia
Arm Type
Experimental
Arm Description
PENG block + multimodal IV analgesia (Nefopam, Paracetamol, Morphine)
Arm Title
Multimodal analgesia alone
Arm Type
Active Comparator
Arm Description
Multimodal IV analgesia (Nefopam, Paracetamol, Morphine)
Intervention Type
Combination Product
Intervention Name(s)
PENG Block
Intervention Description
With the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer is then slid medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks. Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 100 mg of ropivacaine is then deposited in this plane, lifting the psoas tendon.
Intervention Type
Combination Product
Intervention Name(s)
Multimodal analgesia
Intervention Description
Multimodal analgesia is administered to patients as follows : 2-3 mg of morphine (2mg if patient's weight <60kg; 3mg if patient's weight >60kg) + Paracetamol 1g/8h and Nefopam 20mg/8h. Frequency of morphine administration depends on the assessed pain.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Total morphine consumption in mg per hour from admission up to 24 hours after randomization or until surgery if the patient is operated on before 24 hours
Time Frame
Up to 24 hours after randomization
Secondary Outcome Measure Information:
Title
Pain intensity according to a Numeric Rating Scale (NRS)
Description
The patient's pain will be assessed using a Numeric Rating Scale at the start of care in the emergency department, when the clinical suspicion of hip fracture is confirmed by the emergency doctor, then every hour in the emergency room and every 4 hours in the surgery department for 24 hours or until transfer to the operating room if the surgery takes place before. The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
Time Frame
Up to 24 hours after randomization
Title
Presence of side effects
Description
The tolerance of analgesic treatments will be assessed by evaluating the presence or absence of side effects, during the first 24 hours of treatment or until surgery if it takes place before : Side effects related to opioids such as Confusion, Bradypnea, Nausea or vomiting Side effects related to PENG-Block such as Pain at the puncture site, Acute retention of urine, Bleeding Any other adverse effects occurring during the study will be collected.
Time Frame
Up to 24 hours after randomization
Title
Duration of hospitalization in the emergency department
Description
Duration of care in hours at the emergency department.
Time Frame
Up to 24 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (≥18 years old) admitted to the emergency department for a hip fracture Pain assessed by VAS/NRS ≥ 3 when the clinical suspicion of hip fracture is confirmed by the emergency physician Patients capable of expressing his/her consent prior to participation in the study Affiliated to or beneficiary of a social security regimen Exclusion Criteria: Patients for who it is impossible to collect the pain assessment scale 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 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 Pregnant, parturient or breastfeeding women Patients under judicial protection or judicial safeguard Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali CESANA
Phone
04 83 77 20 60
Ext
+33
Email
magali.cesana@ch-toulon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent CAUMON, MD
Organizational Affiliation
Centre Hospitalier de Hyères
Official's Role
Study Director
Facility Information:
Facility Name
Hyères Hospital
City
Hyères
State/Province
Var
ZIP/Postal Code
83400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent CAUMON, MD
Email
laucau1583@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Regional Anesthesia by PENG-Block in Emergency Department

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