Hip FracturesNCT06336460
PENG vs. FIC Blocks in Hip Fractures in the ED
A study testing Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures in people with Hip Fractures and Nerve Block, run by Orange Park Medical Center.
Trial summary
This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Nerve Block, Analgesia
- What is being tested?
- Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- 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
- Adult (>= 18 years of age)
- Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan
- Glasgow Coma Score (GCS) = 15
- Subjective pain score of >= 5 on a scale of 0 to 10 just prior to the nerve block placement
Who cannot join
- Patients who are unable to give consent due to altered mental status or dementia
- Clinically intoxicated patients
- Patients who are unable to communicate their numeric level of pain
- Open fracture or penetrating hip trauma
- Signs of infection or laceration at injection site
- Patients with multi-system trauma
Show all 13Show fewer
- Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of hip fracture pain, e.g. humerus fracture, dislocated joint)
- Requiring immediate surgical intervention (< 1 hour)
- Deemed clinically unstable by treating physician
- Abnormal vital signs (Pulse>120bpm, Systolic blood pressure < 100 mm Hg, Pulse O2 < 95%)
- Patients on long-acting systemic opioid analgesia
- Allergy to amide local anesthetics
- Vulnerable populations including pregnant patients, prisoners, children, elderly dementia patients. All precautions will be taken to avoid coercion, harm and exploitation of these vulnerable populations, thus they are to be excluded from this study. They will receive pain medications as deemed appropriate by their treating physician.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department
This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.
- Conditions
- Hip Fractures, Nerve Block, Analgesia
- Being tested
- Pericapsular Nerve Group (PENG) Block, Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group (PENG) BlockProcedure or surgery
Under sterile technique, physician will identify relevant landmarks including the femoral artery, femoral vein, femoral nerve, ileopubic eminence (IPE), anterior inferior iliac spine (AIIS), psoas tendon (PT). Target area is bony space between AIIS and IPE adjacent to PT.
Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting fascial plane below the psoas tendon, above ilium bone. Landmark lies between the AIIS and IPE, just lateral to psoas tendon.
As needle tip reaches target, small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, lifting the psoas tendon from ilium, confirming proper positioning.
Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).
After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush line of remaining anesthetic. Needle will then be withdrawn.
Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip FracturesProcedure or surgery
Under sterile technique, physician will identify relevant landmarks, including femoral artery, femoral vein, femoral nerve, iliacus muscle with overlying fascia iliaca.
Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting the fascial plane above iliacus muscle.
As needle tip reaches the target, a small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, confirming proper positioning.
Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%).
After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush the line of remaining anesthetic. The needle will then be withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular Nerve Group (PENG) Block | Experimental | Not described Receives: Procedure: Pericapsular Nerve Group (PENG) Block |
| Fascia Iliaca Compartment (FIC) Block | Experimental | Not described Receives: Procedure: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain score at 30 minutes
Measured: 30 minutes after block placement
Numeric pain score at 60 minutes
Measured: 1 hour after block placement
Secondary outcomes (1)
Cumulative Morphine Milligram Equivalents in 24 hours after enrollment
Measured: 24 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orange Park Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taryn Hoffman, MD, Principal investigator, HCA Florida Orange Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336460
- Sponsor's protocol ID
- 2023-537
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhoi S, Chandra A, Galwankar S. Ultrasound-guided nerve blocks in the emergency department. J Emerg Trauma Shock. 2010 Jan;3(1):82-8. doi: 10.4103/0974-2700.58655.
PubMed 20165729Pasquier M, Taffe P, Hugli O, Borens O, Kirkham KR, Albrecht E. Fascia iliaca block in the emergency department for hip fracture: a randomized, controlled, double-blind trial. BMC Geriatr. 2019 Jul 1;19(1):180. doi: 10.1186/s12877-019-1193-0.
PubMed 31262265Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Luftig J, Dreyfuss A, Mantuani D, Howell K, White A, Nagdev A. A new frontier in pelvic fracture pain control in the ED: Successful use of the pericapsular nerve group (PENG) block. Am J Emerg Med. 2020 Dec;38(12):2761.e5-2761.e9. doi: 10.1016/j.ajem.2020.05.085. Epub 2020 May 28.
PubMed 32532621Marrone F, Graziano G, Paventi S, Tomei M, Gucciardino P, Bosco M. Analgesic efficacy of Pericapsular Nerve Group (PENG) block compared with Fascia Iliaca Block (FIB) in the elderly patient with fracture of the proximal femur in the emergency room. A randomised controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Nov;70(9):501-508. doi: 10.1016/j.redare.2022.10.010. Epub 2023 Sep 6.
PubMed 37678449Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
PubMed 34290085
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department
- ClinicalTrials.gov ID
- NCT06336460
- Acronym / sponsor ID
- 2023-537
- Conditions
- Hip Fractures, Nerve Block, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Orange Park Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 28 Mar 2024 (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.
This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular Nerve Group (PENG) Block | Experimental | Procedure: Pericapsular Nerve Group (PENG) Block |
| Fascia Iliaca Compartment (FIC) Block | Experimental | Procedure: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>= 18 years of age)
- Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan
- Glasgow Coma Score (GCS) = 15
- Subjective pain score of >= 5 on a scale of 0 to 10 just prior to the nerve block placement
Key exclusion criteria (13 listed)
- Patients who are unable to give consent due to altered mental status or dementia
- Clinically intoxicated patients
- Patients who are unable to communicate their numeric level of pain
- Open fracture or penetrating hip trauma
- Signs of infection or laceration at injection site
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 (PENG) BlockUnder sterile technique, physician will identify relevant landmarks including the femoral artery, femoral vein, femoral nerve, ileopubic eminence (IPE), anterior inferior iliac spine (AIIS), psoas tendon (PT). Target area is bony space between AIIS and IPE adjacent to PT. Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting fascial plane below the psoas tendon, above ilium bone. Landmark lies between the AIIS and IPE, just lateral to psoas tendon. As needle tip reaches target, small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, lifting the psoas tendon from ilium, confirming proper positioning. Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%). After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush line of remaining anesthetic. Needle will then be withdrawn. | Procedure or surgery | Pericapsular Nerve Group (PENG) Block |
| Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip FracturesUnder sterile technique, physician will identify relevant landmarks, including femoral artery, femoral vein, femoral nerve, iliacus muscle with overlying fascia iliaca. Using in-plane technique with constant visualization, needle will be inserted through skin and soft tissue targeting the fascial plane above iliacus muscle. As needle tip reaches the target, a small volume of normal saline will be injected to hydrodissect tissue. Fluid will start to spread along fascial plane, confirming proper positioning. Normal saline will then be switched to anesthetic (30mL of Bupivacaine 0.25%). After full volume of anesthetic has been injected, a small volume (5mL) of normal saline will be injected to flush the line of remaining anesthetic. The needle will then be withdrawn. | Procedure or surgery | Fascia Iliaca Compartment (FIC) Block |
Primary outcome
Numeric pain score at 30 minutes
Time frame: 30 minutes after block placement
Numeric pain score at 60 minutes
Time frame: 1 hour after block placement
1 secondary outcome
Cumulative Morphine Milligram Equivalents in 24 hours after enrollment
Time frame: 24 hours after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 20165729Bhoi S, Chandra A, Galwankar S. Ultrasound-guided nerve blocks in the emergency department. J Emerg Trauma Shock. 2010 Jan;3(1):82-8. doi: 10.4103/0974-2700.58655.
- Background: PubMed 31262265Pasquier M, Taffe P, Hugli O, Borens O, Kirkham KR, Albrecht E. Fascia iliaca block in the emergency department for hip fracture: a randomized, controlled, double-blind trial. BMC Geriatr. 2019 Jul 1;19(1):180. doi: 10.1186/s12877-019-1193-0.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 32532621Luftig J, Dreyfuss A, Mantuani D, Howell K, White A, Nagdev A. A new frontier in pelvic fracture pain control in the ED: Successful use of the pericapsular nerve group (PENG) block. Am J Emerg Med. 2020 Dec;38(12):2761.e5-2761.e9. doi: 10.1016/j.ajem.2020.05.085. Epub 2020 May 28.
- Background: PubMed 37678449Marrone F, Graziano G, Paventi S, Tomei M, Gucciardino P, Bosco M. Analgesic efficacy of Pericapsular Nerve Group (PENG) block compared with Fascia Iliaca Block (FIB) in the elderly patient with fracture of the proximal femur in the emergency room. A randomised controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Nov;70(9):501-508. doi: 10.1016/j.redare.2022.10.010. Epub 2023 Sep 6.
- Background: PubMed 34290085Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
- 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.
Taryn Hoffman, MD principal investigator
HCA Florida Orange Park Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures in people with Hip Fractures and Nerve Block, run by Orange Park Medical Center.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taryn Hoffman, MD ((904) 639 - 8500, taryn_hoffman@teamhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain score at 30 minutes (time frame: 30 minutes after block placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336460, which also lists 6 linked publications.
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 28 Mar 2024.