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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06336460
Other study ID # 2023-537
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2026

Study information

Verified date March 2024
Source Orange Park Medical Center
Contact Taryn Hoffman, MD
Phone (904) 639 - 8500
Email taryn_hoffman@teamhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Orange Park Medical Center

References & Publications (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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain score at 30 minutes 30 minutes after block placement
Primary Numeric pain score at 60 minutes 1 hour after block placement
Secondary Cumulative Morphine Milligram Equivalents in 24 hours after enrollment 24 hours after enrollment
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