Clinical trial NCT06336460: PENG vs. FIC Blocks in Hip Fractures in the ED
Official title: Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures
Nerve Block
Analgesia
Lead sponsor: Orange Park Medical Center
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numeric pain score at 30 minutes
timeFrame: 30 minutes after block placement
measure: Numeric pain score at 60 minutes
timeFrame: 1 hour after block placement
Secondary outcomes:
measure: Cumulative Morphine Milligram Equivalents in 24 hours after enrollment
timeFrame: 24 hours after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: HCA Florida Orange Park Hospital
name: Taryn Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.