- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914988
Continuous Fascia Iliaca Compartment Block in Geriatric Hip Fracture
Pain Management in Geriatric Hip Fracture Patients With Ultrasound-guided Continuous Fascia Iliaca Compartment Block
The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB at Emergency Department or patient's ward.
The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.
Study Overview
Status
Conditions
Detailed Description
The Enhance Recovery Program of pain management in geriatric hip fracture has been set up as a part of fast track at Siriraj Hospital since September 2017. The ultrasound-guided (USG) fascia iliaca compartment block (FICB) is routinely offered to patients with a hip fracture by acute pain service (APS) anesthesiologist. The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB.
The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient age equal or more than 65 years old
- patient with acute hip fracture within 7 days
- patient with NRS ≥ 5
Exclusion Criteria:
- patient refusal
- history of local anesthetic allergy
- inability to communicate or cognitive dysfunction
- multiple fracture involvement
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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numerical rating scale at rest
Time Frame: Change from baseline numerical rating scale at 30 minutes post-block
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numerical rating scale 0-10 (0=no pain, 10=worst pain)
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Change from baseline numerical rating scale at 30 minutes post-block
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numerical rating scale during movement
Time Frame: Change from baseline numerical rating scale at 30 minutes post-block
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numerical rating scale 0-10 (0=no pain, 10=worst pain)
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Change from baseline numerical rating scale at 30 minutes post-block
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale during movement
Time Frame: Within 48 hours postoperative
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numerical rating scale 0-10 (0=no pain, 10=worst pain)
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Within 48 hours postoperative
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Rate of complications of continuous fascia iliaca compartment analgesia
Time Frame: Within 48 hours postoperative
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local anesthetic systemic toxicity, leakage, infection
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Within 48 hours postoperative
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Duration of hospital admission
Time Frame: from hospital admission until hospital discharge, an average of 1 week
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number of days
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from hospital admission until hospital discharge, an average of 1 week
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Number of participants with morbidity and mortality
Time Frame: 6 weeks after hospital discharge
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myocardial disease, deep vein thrombosis, delirium, death
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6 weeks after hospital discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University
Publications and helpful links
General Publications
- Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
- White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.
- Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.
- Orosz GM, Magaziner J, Hannan EL, Morrison RS, Koval K, Gilbert M, McLaughlin M, Halm EA, Wang JJ, Litke A, Silberzweig SB, Siu AL. Association of timing of surgery for hip fracture and patient outcomes. JAMA. 2004 Apr 14;291(14):1738-43. doi: 10.1001/jama.291.14.1738.
- Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
- Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
- Ftouh S, Morga A, Swift C; Guideline Development Group. Management of hip fracture in adults: summary of NICE guidance. BMJ. 2011 Jun 21;342:d3304. doi: 10.1136/bmj.d3304. No abstract available.
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
- Si 113/2018
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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