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Hip FracturesNCT04210700

Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control

A study testing Fascia iliaca compartment block and Pericapsular nerve group block in people with Hip Fractures and Analgesia, run by Mackay Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hip Fractures, Analgesia, Nerve Blocks
What is being tested?
Fascia iliaca compartment block and Pericapsular nerve group block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
8 Jan 2020to 4 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for surgical treatment for hip fracture
  • American Society of Anesthesiologists (ASA) physical status I-III

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Mackay Memorial Hospital

    New Taipei City, 25160

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Fascia iliaca compartment block, Pericapsular nerve group block
Medical subject headings
Hip Fractures, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fascia iliaca compartment blockProcedure or surgery

    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.

  • Pericapsular nerve group blockProcedure or surgery

    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.

Study groups in NCT04210700
Study groupRoleWhat they receive
Fascia iliaca compartment blockActive comparatorParticipants will receive fascia iliaca compartment block before spinal anesthesia and operation
Receives: Procedure: Fascia iliaca compartment block
Pericapsular nerve group block groupExperimentalParticipants will receive pericapsular nerve group block before spinal anesthesia and operation
Receives: Procedure: Pericapsular nerve group block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain measurement at rest

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

    Measured: 30 minutes after nerve blocks

  2. Pain measurement during internal rotation

    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

    Measured: 30 minutes after nerve blocks

Secondary outcomes (13)
  1. Pain measurement at rest

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

    Measured: 10 minutes after nerve block

  2. Pain measurement during internal rotation

    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

    Measured: 10 minutes after nerve block

  3. Pain measurement at rest

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

    Measured: 20 minutes after nerve block

  4. Pain measurement during internal rotation

    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

    Measured: 20 minutes after nerve block

  5. pain measurement during positioning for spinal anesthesia

    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

    Measured: Just before operation

  6. pain measurement after operation

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)

    Measured: 6, 12, and 24 hours after operation

  7. the time spending for performing spinal anesthesia

    defined as starting of positioning maneuver to removal of spinal needle

    Measured: Just before operation

  8. quality of position for spinal anesthesia

    characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia

    Measured: Just before operation

  9. the first time of pain perceived by the patient after operation

    the time interval between the end of operation and pain first perceived by the patient

    Measured: Within 48 hours after operation

  10. the time of first request for rescue analgesics after operation

    the time interval between the end of operation and the first request for rescue analgesics

    Measured: Within 48 hours after operation

  11. total consumption of rescue analgesics within 24 hours after the operation

    total consumption of rescue analgesics within 24 hours after the operation

    Measured: Within 24 hours after the operation

  12. the first time of ambulation after operation

    the time interval between the end of operation and the first time the patient can ambulate with assistance after operation

    Measured: Within 72 hours after operation

  13. the time spending for nerve block

    defined as from contact of skin by the ultrasound transducer to removal of the needle

    Measured: Before operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start8 Jan 2020
  3. Primary completion31 May 2023
  4. Study completion4 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210700
Sponsor's protocol ID
19MMHIS254e
Status last verified
Mar 2024
First submitted
19 Dec 2019
Last updated
22 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16983459
  • 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.

    PubMed 1421796
  • 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.

    PubMed 29166235
  • 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.

    PubMed 23758305
  • 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.

    PubMed 25068412
  • 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.

    PubMed 29793602
  • 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.

    PubMed 30063657
  • 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.

    PubMed 28059869
  • 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.

    PubMed 30798268
  • 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.

    PubMed 15755432

Questions about this trial

What is this clinical trial studying?

A study testing Fascia iliaca compartment block and Pericapsular nerve group block in people with Hip Fractures and Analgesia, run by Mackay Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain measurement at rest (time frame: 30 minutes after nerve blocks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210700, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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