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

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pericapsular nerve Group Block
Infrainguinal Fascia Iliaca Block
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Fascia iliaca block, PENG block, Regional anaesthesia at Emergency Departments, Hip Fracture Analgesia

Eligibility Criteria

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

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)

Sites / Locations

  • Emergency Department, IRCCS San Matteo University HospitalRecruiting
  • Emergency Department, Colchester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PENG block: Study group

Infrainguinal fascia iliaca block: Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (derived from V AS measurement at T0-T1- T2-T3-T4 as described above)

Secondary Outcome Measures

33% SPID 33% (33%SPID)
Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID)
50%SPID
Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID)
Quantity of opioids
Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block
Adverse events
Occurrence of adverse events including nausea or vomiting, hypotension, respiratory depression (hypoxia or hypopnea), local anaesthetic toxicity syndrome (LAST syndrome) during ED stay (post-block). Adverse event will be described, and their incidence will be presented with 95% CI and compared with Fisher test.

Full Information

First Posted
May 7, 2022
Last Updated
August 11, 2022
Sponsor
IRCCS Policlinico S. Matteo
Collaborators
Colchester General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05370586
Brief Title
PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures
Official Title
Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Multicenter, Single- Blind, Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
Collaborators
Colchester General Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Fascia iliaca block, PENG block, Regional anaesthesia at Emergency Departments, Hip Fracture Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
andomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the study or control group. The study group will be treated with PENG block following randomisation, whereas the control group will receive the standard treatment, i.e., fascia iliaca block. The study aims to demonstrate the superiority of the new intervention over the standard approach.
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG block: Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Infrainguinal fascia iliaca block: Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pericapsular nerve Group Block
Intervention Description
Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
Intervention Type
Other
Intervention Name(s)
Infrainguinal Fascia Iliaca Block
Intervention Description
Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone
Primary Outcome Measure Information:
Title
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
Description
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (derived from V AS measurement at T0-T1- T2-T3-T4 as described above)
Time Frame
Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary Outcome Measure Information:
Title
33% SPID 33% (33%SPID)
Description
Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID)
Time Frame
Outcome assessed within 60 minutes following the block (PENG or FIB)
Title
50%SPID
Description
Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID)
Time Frame
Outcome assessed within 60 minutes following the block (PENG or FIB)
Title
Quantity of opioids
Description
Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block
Time Frame
Outcome assessed within 60 minutes following the block (PENG or FIB)
Title
Adverse events
Description
Occurrence of adverse events including nausea or vomiting, hypotension, respiratory depression (hypoxia or hypopnea), local anaesthetic toxicity syndrome (LAST syndrome) during ED stay (post-block). Adverse event will be described, and their incidence will be presented with 95% CI and compared with Fisher test.
Time Frame
Outcome assessed within 60 minutes following the block (PENG or FIB)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santi Di Pietro, MD
Phone
00393463153244
Email
santi.dipietro01@universitadipavia.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santi Di Pietro, MD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department, IRCCS San Matteo University Hospital
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santi Di Pietro, MD
Phone
0039 3463153244
Email
santi.dipietro01@universitadipavia.it
Facility Name
Emergency Department, Colchester General Hospital
City
Colchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattia Kolletzek, PI

12. IPD Sharing Statement

Plan to Share IPD
No

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

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