Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-01
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pericapsular Nerve Group (PENG) Block
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 Needle will then be withdrawn.
Fascia Iliaca Compartment (FIC) Block
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Orange Park Medical Center
OTHER
Responsible Party
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Principal Investigators
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Taryn Hoffman, MD
Role: PRINCIPAL_INVESTIGATOR
HCA Florida Orange Park Hospital
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2023-537
Identifier Type: -
Identifier Source: org_study_id
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