PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures

NCT ID: NCT05370586

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-30
• Study Completion Date: 2024-08-16

Brief Summary

Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK).

The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of "pain intensity difference"), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PENG block: Study group

Patients enrolled in the study group will receive a PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone. The block will be performed with the patient in a supine position using an 18-gauge, 90 mm needle, inserted with an in-plane lateral to medial approach. Operators will use the original technique described by Girón-Arango L et al. The aim of this block is to inject the local anaesthetic between the psoas tendon and the iliopubic eminence. We will instruct operators to routinely use a curvilinear probe (2-6 MHz) or a linear probe (4-16 MHz) in particularly lean or cachectic patients.

Group Type: EXPERIMENTAL

Pericapsular nerve Group Block

Intervention Type: OTHER

Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone

Infrainguinal fascia iliaca block: Control group

Patients allocated in the control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone, using an 18-gauge, 90 mm needle, inserted with an in-plane lateral to medial approach.

The probe (linear 4-16 MHz) is placed transversely at the inguinal crease to identify the femoral artery, femoral nerve, iliopsoas muscle and the fascia iliaca over the psoas muscle. Moving the probe laterally the sartorius muscle and the anterior inferior iliac spine (AIIS) can be identified. After skin disinfection the needle is inserted placing the tip beneath the fascia iliaca at the lateral third of a line between the AIIS and pubic tubercle. Correct needle placement is confirmed by separation of the fascia iliaca from the iliopsoas muscle upon injection, with local anaesthetic spreading towards the FN medially and the iliac crest laterally.

Group Type: OTHER

Infrainguinal Fascia Iliaca Block

Intervention Type: OTHER

Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone

Interventions

Pericapsular nerve Group Block

Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone

Intervention Type: OTHER

Infrainguinal Fascia Iliaca Block

Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >18
• Capacity to understand the aim of the study, the potential benefits and side-effects of the procedures
• Capacity to provide consent
• Capacity to provide a self-assessment of pain using the written VAS Scale
• Confirmed radiological diagnosis of hip fractures (including subcapitate, transcervical, intertrochanteric and perthrocanteric fractures)
• Moderate or severe worst pain (visual analogue scale, VAS >40 mm) (at rest or dynamic)

Exclusion Criteria

• Known hypersensitivity to local anaesthetics
• Confirmed radiological diagnosis of subtrochanteric or diaphyseal femur fractures
• Hemodynamic instability
• Known diagnosis of severe cognitive impairment
• Dementia and/or delirium (defined by a 4AT score ≥ 2)
• Lack of capacity to provide consent and to understand the aim of the study
• BMI>35
• Body weight < 40 Kg
• Prior hip surgery on the same fracture side
• Mild worst pain (visual analogue scale, VAS < 40 mm) (at rest or dynamic)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colchester General Hospital

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Santi Di Pietro

MD, PhD - Emergency Medicine Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santi Di Pietro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Matteo Foundation - University of Pavia

Locations

Emergency Department, IRCCS San Matteo University Hospital

Pavia, Lombardy, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

0020199/22

Identifier Type: -

Identifier Source: org_study_id