PENG vs. FIC Blocks in Hip Fractures in the ED

NCT ID: NCT06336460

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures Nerve Block Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pericapsular Nerve Group (PENG) Block

Group Type EXPERIMENTAL

Pericapsular Nerve Group (PENG) Block

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pericapsular Nerve Group (PENG) Block

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.

Intervention Type PROCEDURE

Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orange Park Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Taryn Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

HCA Florida Orange Park Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Taryn Hoffman, MD

Role: CONTACT

(904) 639 - 8500

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20165729 (View on PubMed)

Pasquier 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.

Reference Type BACKGROUND
PMID: 31262265 (View on PubMed)

Giron-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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

Luftig 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.

Reference Type BACKGROUND
PMID: 32532621 (View on PubMed)

Marrone 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.

Reference Type BACKGROUND
PMID: 37678449 (View on PubMed)

Aliste 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.

Reference Type BACKGROUND
PMID: 34290085 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-537

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.