Hip FracturesNCT04914988
Continuous Fascia Iliaca Compartment Block in Geriatric Hip Fracture
An observational study of Hip Fractures and Acute Pain Due to Trauma, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Acute Pain Due to Trauma
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2018to 15 Feb 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Acute hip fracture in elderly
Who may be able to join
- patient age equal or more than 65 years old
- patient with acute hip fracture within 7 days
- patient with NRS ≥ 5
Who cannot join
- patient refusal
- history of local anesthetic allergy
- inability to communicate or cognitive dysfunction
- multiple fracture involvement
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures, Acute Pain Due to Trauma
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale at rest
numerical rating scale 0-10 (0=no pain, 10=worst pain)
Measured: Change from baseline numerical rating scale at 30 minutes post-block
numerical rating scale during movement
numerical rating scale 0-10 (0=no pain, 10=worst pain)
Measured: Change from baseline numerical rating scale at 30 minutes post-block
Secondary outcomes (4)
Numerical rating scale during movement
numerical rating scale 0-10 (0=no pain, 10=worst pain)
Measured: Within 48 hours postoperative
Rate of complications of continuous fascia iliaca compartment analgesia
local anesthetic systemic toxicity, leakage, infection
Measured: Within 48 hours postoperative
Duration of hospital admission
number of days
Measured: from hospital admission until hospital discharge, an average of 1 week
Number of participants with morbidity and mortality
myocardial disease, deep vein thrombosis, delirium, death
Measured: 6 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Feb 2018
- Primary completion30 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Tangwiwat, Mahidol University
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914988
- Sponsor's protocol ID
- Si 113/2018
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26940645Guay 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.
PubMed 26899415Orosz 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.
PubMed 15082701Birnbaum 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.
PubMed 9479711Guay 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.
PubMed 28494088Hebbard 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.
PubMed 21401544Ftouh 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.
PubMed 21693526
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Geriatric Hip Fracture Patients With Ultrasound-guided Continuous Fascia Iliaca Compartment Block
- ClinicalTrials.gov ID
- NCT04914988
- Acronym / sponsor ID
- Si 113/2018
- Conditions
- Hip Fractures, Acute Pain Due to Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Acute hip fracture in elderly
Key inclusion criteria (3 listed)
- patient age equal or more than 65 years old
- patient with acute hip fracture within 7 days
- patient with NRS ≥ 5
Key exclusion criteria (4 listed)
- patient refusal
- history of local anesthetic allergy
- inability to communicate or cognitive dysfunction
- multiple fracture involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
numerical rating scale at rest
Time frame: Change from baseline numerical rating scale at 30 minutes post-block
numerical rating scale 0-10 (0=no pain, 10=worst pain)
numerical rating scale during movement
Time frame: Change from baseline numerical rating scale at 30 minutes post-block
numerical rating scale 0-10 (0=no pain, 10=worst pain)
4 secondary outcomes
Numerical rating scale during movement
Time frame: Within 48 hours postoperative
Rate of complications of continuous fascia iliaca compartment analgesia
Time frame: Within 48 hours postoperative
Duration of hospital admission
Time frame: from hospital admission until hospital discharge, an average of 1 week
Number of participants with morbidity and mortality
Time frame: 6 weeks after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Results publication: PubMed 26940645White 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.
- Results publication: PubMed 26899415Guay 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.
- Results publication: PubMed 15082701Orosz 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.
- Results publication: PubMed 9479711Birnbaum 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.
- Results publication: PubMed 28494088Guay 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.
- Results publication: PubMed 21401544Hebbard 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.
- Results publication: PubMed 21693526Ftouh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwimon Tangwiwat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Acute Pain Due to Trauma, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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 7 Jun 2021. 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 Thailand. 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?
numerical rating scale at rest (time frame: Change from baseline numerical rating scale at 30 minutes post-block). 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 NCT04914988, which also lists 7 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 7 Jun 2021.