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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04914988
Other study ID # Si 113/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date February 15, 2019

Study information

Verified date June 2021
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 15, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Locations

Country Name City State
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View Citation

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. — View Citation

Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2:CD000521. doi: 10.1002/14651858.CD000521.pub3. Review. — View Citation

Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5:CD001159. doi: 10.1002/14651858.CD001159.pub2. Review. Update in: Cochrane Database Syst Rev. 2020 Nov 25;11:CD001159. — View Citation

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. — View Citation

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. — View Citation

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 o — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary numerical rating scale at rest numerical rating scale 0-10 (0=no pain, 10=worst pain) Change from baseline numerical rating scale at 30 minutes post-block
Primary numerical rating scale during movement numerical rating scale 0-10 (0=no pain, 10=worst pain) Change from baseline numerical rating scale at 30 minutes post-block
Secondary Numerical rating scale during movement numerical rating scale 0-10 (0=no pain, 10=worst pain) Within 48 hours postoperative
Secondary Rate of complications of continuous fascia iliaca compartment analgesia local anesthetic systemic toxicity, leakage, infection Within 48 hours postoperative
Secondary Duration of hospital admission number of days from hospital admission until hospital discharge, an average of 1 week
Secondary Number of participants with morbidity and mortality myocardial disease, deep vein thrombosis, delirium, death 6 weeks after hospital discharge
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