Continuous Fascia Iliaca Compartment Block in Geriatric Hip Fracture

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04914988

Collaborator

(none)

Enrollment

Location

12.5

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures Acute Pain Due to Trauma

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Pain Management in Geriatric Hip Fracture Patients With Ultrasound-guided Continuous Fascia Iliaca Compartment Block

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Jan 30, 2019

Actual Study Completion Date :

Feb 15, 2019

Outcome Measures

Primary Outcome Measures

numerical rating scale at rest [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 [Change from baseline numerical rating scale at 30 minutes post-block]
numerical rating scale 0-10 (0=no pain, 10=worst pain)

Secondary Outcome Measures

Numerical rating scale during movement [Within 48 hours postoperative]
numerical rating scale 0-10 (0=no pain, 10=worst pain)
Rate of complications of continuous fascia iliaca compartment analgesia [Within 48 hours postoperative]
local anesthetic systemic toxicity, leakage, infection
Duration of hospital admission [from hospital admission until hospital discharge, an average of 1 week]
number of days
Number of participants with morbidity and mortality [6 weeks after hospital discharge]
myocardial disease, deep vein thrombosis, delirium, death

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suwimon Tangwiwat, Department of Anesthesiology, Mahidol University

ClinicalTrials.gov Identifier:

NCT04914988

Other Study ID Numbers:

Si 113/2018

First Posted:

Jun 7, 2021

Last Update Posted:

Jun 7, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Pain

Fractures, Bone

Hip Fractures

Study Results

No Results Posted as of Jun 7, 2021