Pain Relief in Proximal Femoral FractureNCT04278807
PENG-block Versus FIB-block in Emergency Room
A study testing Regional Anesthesia - Nerve Blocks in people with Pain Relief in Proximal Femoral Fracture, run by Santo Spirito Hospital, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Pain Relief in Proximal Femoral Fracture
- What is being tested?
- Regional Anesthesia - Nerve Blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2020to 19 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Pain Relief in Proximal Femoral Fracture
- Being tested
- Regional Anesthesia - Nerve Blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Anesthesia - Nerve BlocksProcedure or surgery
Regional Anesthesia and ultrasound-guided nerve blocks
| Study group | Role | What they receive |
|---|---|---|
| PENG-group | Experimental | Ultrasound-guided PENG-block - 30 patients Receives: Procedure: Regional Anesthesia - Nerve Blocks |
| FIB-group | Experimental | Ultrasound-guided Fascia Iliaca block - 30 patients Receives: Procedure: Regional Anesthesia - Nerve Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes after the placement of nerve block
Secondary outcomes (4)
Onset time and duration of nerve blockade
First request of analgesic medication after blockade
Measured: from 30 minutes to 12 hours
Evaluation of rest and incident pain
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain)
Measured: 30 minutes after the placement of nerve block
Use of rescue-medication in pain treatment
Analgesic drugs administered at the request of the patient in the case of blockade failure
Measured: from 30 minutes to 12 hours
Check for any complications related to analgesic (PENG and FIB) blocks
Recording of any complications related to PENG and FIB blocks
Measured: from 30 minutes to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start14 Feb 2020
- Primary completion19 Sep 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief in Proximal Femoral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santo Spirito Hospital, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Francesco Marrone, Santo Spirito Hospital, Italy
- Investigators
- Francesco Marrone, Principal investigator, UOC Anestesia e Rianimazione Santo Spirito Hospital Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278807
- Sponsor's protocol ID
- SSH_PENG_Trial
- Status last verified
- Sep 2021
- First submitted
- 18 Feb 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04278807
- Acronym / sponsor ID
- SSH_PENG_Trial
- Conditions
- Pain Relief in Proximal Femoral Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Santo Spirito Hospital, ItalyUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG-group | Experimental | Procedure: Regional Anesthesia - Nerve BlocksUltrasound-guided PENG-block - 30 patients |
| FIB-group | Experimental | Procedure: Regional Anesthesia - Nerve BlocksUltrasound-guided Fascia Iliaca block - 30 patients |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional Anesthesia - Nerve BlocksRegional Anesthesia and ultrasound-guided nerve blocks | Procedure or surgery | FIB-group, PENG-group |
Primary outcome
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).
Time frame: 30 minutes after the placement of nerve block
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).
4 secondary outcomes
Onset time and duration of nerve blockade
Time frame: from 30 minutes to 12 hours
Evaluation of rest and incident pain
Time frame: 30 minutes after the placement of nerve block
Use of rescue-medication in pain treatment
Time frame: from 30 minutes to 12 hours
Check for any complications related to analgesic (PENG and FIB) blocks
Time frame: from 30 minutes to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Marrone principal investigator
UOC Anestesia e Rianimazione Santo Spirito Hospital Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Anesthesia - Nerve Blocks in people with Pain Relief in Proximal Femoral Fracture, run by Santo Spirito Hospital, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 30 minutes after the placement of nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.