Back to resultsPENG-block Versus FIB-block in Emergency Room
Primary Purpose
Pain Relief in Proximal Femoral Fracture
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Regional Anesthesia - Nerve Blocks
Sponsored by
About this trial
This is an interventional treatment trial for Pain Relief in Proximal Femoral Fracture
Eligibility Criteria
Inclusion Criteria:
- all patients > 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).
Exclusion Criteria:
- Failure to acquire written and valid informed consent
- ASA > 3
- Obesity (BMI> 35 kg / m2)
- Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics)
- Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions;
- History of alcohol or drug abuse;
- Severe kidney or liver failure;
- Cognitive alterations, dementia, psychiatric pathologies
Sites / Locations
- Santo Spirito Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PENG-group
FIB-group
Arm Description
Ultrasound-guided PENG-block - 30 patients
Ultrasound-guided Fascia Iliaca block - 30 patients
Outcomes
Primary Outcome Measures
Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4).
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).
Secondary Outcome Measures
Onset time and duration of nerve blockade
First request of analgesic medication after blockade
Evaluation of rest and incident pain
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain)
Use of rescue-medication in pain treatment
Analgesic drugs administered at the request of the patient in the case of blockade failure
Check for any complications related to analgesic (PENG and FIB) blocks
Recording of any complications related to PENG and FIB blocks
Full Information
NCT ID
NCT04278807
First Posted
February 18, 2020
Last Updated
September 20, 2021
Sponsor
Santo Spirito Hospital, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04278807
Brief Title
PENG-block Versus FIB-block in Emergency Room
Official Title
Analgesic Efficacy of PENG Block Compared to FIB Block in the Elderly Patient With Fracture of the Proximal Femur in the Emergency Room
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
September 19, 2021 (Actual)
Study Completion Date
September 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santo Spirito Hospital, Italy
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 trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve Group) block compared to iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of proximal femur in emergency room.
Detailed Description
Prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of the proximal femur in emergency room.
The study will cover patients aged > 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Relief in Proximal Femoral Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENG-group
Arm Type
Experimental
Arm Description
Ultrasound-guided PENG-block - 30 patients
Arm Title
FIB-group
Arm Type
Experimental
Arm Description
Ultrasound-guided Fascia Iliaca block - 30 patients
Intervention Type
Procedure
Intervention Name(s)
Regional Anesthesia - Nerve Blocks
Intervention Description
Regional Anesthesia and ultrasound-guided nerve blocks
Primary Outcome Measure Information:
Title
Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4).
Description
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).
Time Frame
30 minutes after the placement of nerve block
Secondary Outcome Measure Information:
Title
Onset time and duration of nerve blockade
Description
First request of analgesic medication after blockade
Time Frame
from 30 minutes to 12 hours
Title
Evaluation of rest and incident pain
Description
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain)
Time Frame
30 minutes after the placement of nerve block
Title
Use of rescue-medication in pain treatment
Description
Analgesic drugs administered at the request of the patient in the case of blockade failure
Time Frame
from 30 minutes to 12 hours
Title
Check for any complications related to analgesic (PENG and FIB) blocks
Description
Recording of any complications related to PENG and FIB blocks
Time Frame
from 30 minutes to 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients > 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).
Exclusion Criteria:
Failure to acquire written and valid informed consent
ASA > 3
Obesity (BMI> 35 kg / m2)
Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics)
Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions;
History of alcohol or drug abuse;
Severe kidney or liver failure;
Cognitive alterations, dementia, psychiatric pathologies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Marrone
Organizational Affiliation
UOC Anestesia e Rianimazione Santo Spirito Hospital Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santo Spirito Hospital
City
Rome
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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PENG-block Versus FIB-block in Emergency Room
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