- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210700
Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control
Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation
The aim of the study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control. The participants, caregivers, and assessors will be blinded to the type of block the participants receive. Patients aged 20 years or older with hip fracture scheduled for surgical treatment will be assessed for eligibility to participate the study. One hundred eligible patients will be included in the study after informed consents are obtained, and then randomly allocated into either FIC block or PENG block, with 50 patients in each group. Both blocks will performed under ultrasound guidance.
The followings will be assessed: the numerical rating pain scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) at before and after nerve block at different time points during rest and passive internal rotation of the fractured lower limb to neutral position from its typical external rotation deformity 30 mins after block (primary outcome). The degree of patient's satisfaction regarding nerve blocks and anesthesiologist's satisfaction regarding patient position during spinal anesthesia will also be assessed. The pain and use of rescue analgesics in the first 24 hours after operation will be recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control before operation.
Methods This will be a randomized, assessor and participant-blinded study. After the patients give his /her informed consents, his/her baseline demographic data (gender, age, height, and body weight) and types of hip fracture will be recorded. Participants will be randomly allocated into either FIC block or PENG block by using the website RESEARCH RANDOMIZER (https://www.randomizer.org). One of the two anesthesiologists experienced in performed the FIC and PENG blocks will perform the nerve blocks. Only the anesthesiologist performing the nerve block and his assistant will be aware of which nerve block the participant receives immediately before performing nerve block by opening a sealed envelope. The assessors, in-charge anesthesiologists and nurse anesthetists, operation room personnel, surgeons and study participants will be all blinded to the randomization.
On arrival of the operating theater, all participants will be sent to the nerve block area, where continuous electrocardiogram, pulse oximetry, and non-invasive intermittent blood pressure monitoring will be applied and an intravenous line will be established. Before any intervention, pain at rest and during the fractured lower limb being passively internal rotated in extension to neutral position from its usual externally rotated deformity by assessors will assessed using NRS. If the participant cannot tolerate passive internal rotation of his/her fractured limb due to pain, impossibility to perform the test will be recorded as well as the worst NRS score during these attempts. The same assessment will be performed every 10 mins for until 30 mins after completion of the nerve block. Then the patient will be sent to the operation room, where spinal anesthesia will be performed for the surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sheng-Chin Kao, MD
- Phone Number: 886-975835727
- Email: sckao1974@gmail.com
Study Locations
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New Taipei City, Taiwan, 25160
- Mackay Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled for surgical treatment for hip fracture
- American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
- allergy to local anesthetics
- pregnancy
- inability to understand and use the numerical rating scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) after instruction
- chronic use of opioids
- coagulopathy
- neuropathy
- severe diabetic mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fascia iliaca compartment block
Participants will receive fascia iliaca compartment block before spinal anesthesia and operation
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A linear ultrasound transducer is placed in a sagittal plane to identify the anterior superior iliac spine.
By sliding the transducer medially, the fascia iliaca and abdominal internal oblique, sartorius, and iliopsoas muscles are identified.
After identifying the "bow-tie sign", a 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from caudal to cephalad until the needle tip penetrate the fascia iliaca.
After negative aspiration, 0.35% ropivacaine 30mL with 1:400,000 epinephrine will be injected to separate the fascia iliaca and the iliacus muscle.
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Experimental: Pericapsular nerve group block group
Participants will receive pericapsular nerve group block before spinal anesthesia and operation
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A curvilinear ultrasound transducer is initially place on the anterior inferior iliac spine and then aligned to the iliopubic eminence by rotating around 45 degree.
In this view, the iliopubic eminence, iliapsoas muscle and tendon, pectineus muscle, femoral artery and vein will be identified.
A 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from lateral to medial until the needle tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.
After negative aspiration, 0.35% ropivacaine 20mL with 1:400,000 epinephrine will be injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain measurement at rest
Time Frame: 30 minutes after nerve blocks
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
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30 minutes after nerve blocks
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Pain measurement during internal rotation
Time Frame: 30 minutes after nerve blocks
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
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30 minutes after nerve blocks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain measurement at rest
Time Frame: 10 minutes after nerve block
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
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10 minutes after nerve block
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Pain measurement during internal rotation
Time Frame: 10 minutes after nerve block
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
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10 minutes after nerve block
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Pain measurement at rest
Time Frame: 20 minutes after nerve block
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
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20 minutes after nerve block
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Pain measurement during internal rotation
Time Frame: 20 minutes after nerve block
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
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20 minutes after nerve block
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pain measurement during positioning for spinal anesthesia
Time Frame: Just before operation
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to lateral decubitus with flexion of the healthy hip
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Just before operation
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pain measurement after operation
Time Frame: 6, 12, and 24 hours after operation
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Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)
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6, 12, and 24 hours after operation
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the time spending for performing spinal anesthesia
Time Frame: Just before operation
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defined as starting of positioning maneuver to removal of spinal needle
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Just before operation
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quality of position for spinal anesthesia
Time Frame: Just before operation
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characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia
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Just before operation
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the first time of pain perceived by the patient after operation
Time Frame: Within 48 hours after operation
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the time interval between the end of operation and pain first perceived by the patient
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Within 48 hours after operation
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the time of first request for rescue analgesics after operation
Time Frame: Within 48 hours after operation
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the time interval between the end of operation and the first request for rescue analgesics
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Within 48 hours after operation
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total consumption of rescue analgesics within 24 hours after the operation
Time Frame: Within 24 hours after the operation
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total consumption of rescue analgesics within 24 hours after the operation
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Within 24 hours after the operation
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the first time of ambulation after operation
Time Frame: Within 72 hours after operation
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the time interval between the end of operation and the first time the patient can ambulate with assistance after operation
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Within 72 hours after operation
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the time spending for nerve block
Time Frame: Before operation
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defined as from contact of skin by the ultrasound transducer to removal of the needle
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Before operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheng-Chin Kao, MD, Mackay Memorial Hospital
Publications and helpful links
General Publications
- Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.
- Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- 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.
- Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.
- Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.
- Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
- Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
- Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
- Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5.
- Candal-Couto JJ, McVie JL, Haslam N, Innes AR, Rushmer J. Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Injury. 2005 Apr;36(4):505-10. doi: 10.1016/j.injury.2004.10.015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19MMHIS254e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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