NCT04914988

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

May 26, 2021

Last Update Submit

June 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Numerical rating scale during movement

    Within 48 hours postoperative

  • Rate of complications of continuous fascia iliaca compartment analgesia

    Within 48 hours postoperative

  • Duration of hospital admission

    from hospital admission until hospital discharge, an average of 1 week

  • Number of participants with morbidity and mortality

    6 weeks after hospital discharge

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute hip fracture in elderly

You may qualify if:

  • patient age equal or more than 65 years old
  • patient with acute hip fracture within 7 days
  • patient with NRS ≥ 5

You may not qualify if:

  • patient refusal
  • history of local anesthetic allergy
  • inability to communicate or cognitive dysfunction
  • multiple fracture involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Suwimon Tangwiwat, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 7, 2021

Study Start

February 1, 2018

Primary Completion

January 30, 2019

Study Completion

February 15, 2019

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations