Regional Anesthesia by PENG-Block in Emergency Department

NCT05673486 | Completed

• 2 other identifiers: 2022-CHITS-0112022-A02203-40
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 24 hours after randomization

Secondary Outcomes (3)

• Pain intensity according to a Numeric Rating Scale (NRS)

  Up to 24 hours after randomization

• Presence of side effects

  Up to 24 hours after randomization

• Duration of hospitalization in the emergency department

  Up to 24 hours after randomization

Study Arms (2)

PENG block + multimodal IV analgesia

EXPERIMENTAL

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

Combination Product: PENG Block; Combination Product: Multimodal analgesia

Multimodal analgesia alone

ACTIVE COMPARATOR

Multimodal IV analgesia (Nefopam, Paracetamol, Morphine)

Combination Product: Multimodal analgesia

Interventions

PENG Block COMBINATION_PRODUCT

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.

PENG block + multimodal IV analgesia

Multimodal analgesia COMBINATION_PRODUCT

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.

Multimodal analgesia alone; PENG block + multimodal IV analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Fondation Apicil: collaborator

Study Sites (1)

Hyères Hospital

Hyères, Var, 83400, France

Location

Related Publications (1)

• Calati P, Lenoir C, Kamel LC, Contie N, Firoloni JD, Sichez A, Sebai A, Chelly J, Caumon L. Effectiveness of pericapsular nerve group block for hip fracture pain management in the emergency department: results of the ED-PENG-B randomised controlled trial. BMC Emerg Med. 2025 Nov 26;25(1):245. doi: 10.1186/s12873-025-01401-x.

  PMID: 41299315 RESULT

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures; Emergencies

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent CAUMON, MD

  Centre Hospitalier de Hyères

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 6, 2023
• Study Start: March 31, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)