PENG-block Versus FIB-block in Emergency Room

NCT04278807 | Completed

• 1 other identifier: SSH_PENG_Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Relief in Proximal Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• 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).

  30 minutes after the placement of nerve block

Secondary Outcomes (4)

• Onset time and duration of nerve blockade

  from 30 minutes to 12 hours

• Evaluation of rest and incident pain

  30 minutes after the placement of nerve block

• Use of rescue-medication in pain treatment

  from 30 minutes to 12 hours

• Check for any complications related to analgesic (PENG and FIB) blocks

  from 30 minutes to 12 hours

Study Arms (2)

PENG-group

EXPERIMENTAL

Ultrasound-guided PENG-block - 30 patients

Procedure: Regional Anesthesia - Nerve Blocks

FIB-group

EXPERIMENTAL

Ultrasound-guided Fascia Iliaca block - 30 patients

Procedure: Regional Anesthesia - Nerve Blocks

Interventions

Regional Anesthesia - Nerve Blocks PROCEDURE

Regional Anesthesia and ultrasound-guided nerve blocks

FIB-group; PENG-group

Eligibility Criteria

• Age: 65 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Santo Spirito Hospital, Italy: lead

Study Sites (1)

Santo Spirito Hospital

Rome, Italy

Location

Study Officials

• Francesco Marrone

  UOC Anestesia e Rianimazione Santo Spirito Hospital Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: February 14, 2020
• Primary Completion: September 19, 2021
• Study Completion: September 19, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)