Hip FracturesNCT05370586
PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures
A study testing Pericapsular nerve Group Block and Infrainguinal Fascia Iliaca Block in people with Hip Fractures, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Pericapsular nerve Group Block and Infrainguinal Fascia Iliaca Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2022to 16 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department, IRCCS San Matteo University Hospital
Pavia, Lombardy, 27100
About this study
Official title: Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.
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
- Being tested
- Pericapsular nerve Group Block, Infrainguinal Fascia Iliaca Block
- Keywords
- Fascia iliaca block, PENG block, Regional anaesthesia at Emergency Departments, Hip Fracture Analgesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve Group BlockOther
Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
Infrainguinal Fascia Iliaca BlockOther
Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| PENG block: Study group | Experimental | 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. Receives: Other: Pericapsular nerve Group Block |
| Infrainguinal fascia iliaca block: Control group | Other | 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. Receives: Other: Infrainguinal Fascia Iliaca Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary outcomes (4)
33% SPID 33% (33%SPID)
Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID)
Measured: Outcome assessed within 60 minutes following the block (PENG or FIB)
50%SPID
Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID)
Measured: Outcome assessed within 60 minutes following the block (PENG or FIB)
Quantity of opioids
Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block
Measured: Outcome assessed within 60 minutes following the block (PENG or FIB)
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.
Measured: Outcome assessed within 60 minutes following the block (PENG or FIB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start30 Jul 2022
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Colchester General Hospital
- Responsible party
- Principal investigator, Santi Di Pietro, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Santi Di Pietro, MD, PhD, Principal investigator, IRCCS San Matteo Foundation - University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370586
- Sponsor's protocol ID
- 0020199/22
- Status last verified
- Sep 2024
- First submitted
- 7 May 2022
- Last updated
- 1 Oct 2024
- Results posted
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05370586
- Acronym / sponsor ID
- 0020199/22
- Conditions
- Hip Fractures
- Keywords
- Fascia iliaca block, PENG block, Regional anaesthesia at Emergency Departments, Hip Fracture Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Colchester General Hospital
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 11 May 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PENG block: Study group | Experimental | Other: Pericapsular nerve Group BlockPatients 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. |
| Infrainguinal fascia iliaca block: Control group | Other | Other: Infrainguinal Fascia Iliaca BlockPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Pericapsular nerve Group BlockPatients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone | Other | PENG block: Study group |
| Infrainguinal Fascia Iliaca BlockPatients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone | Other | Infrainguinal fascia iliaca block: Control group |
Primary outcome
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
Time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)
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)
4 secondary outcomes
33% SPID 33% (33%SPID)
Time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)
50%SPID
Time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)
Quantity of opioids
Time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)
Adverse events
Time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)
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 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Santi Di Pietro, MD, PhD principal investigator
IRCCS San Matteo Foundation - University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve Group Block and Infrainguinal Fascia Iliaca Block in people with Hip Fractures, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 6 inclusion and 10 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 1 Oct 2024. 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?
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (time frame: Outcome assessed within 60 minutes following the block (PENG or FIB)). 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 1 Oct 2024.