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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05403073
Other study ID # 22/027-EC_X
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date February 2023

Study information

Verified date June 2022
Source Hospital San Carlos, Madrid
Contact Borja Alcobía-Díaz, MD, PhD
Phone 913303001
Email dralcobiacot@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.


Description:

Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today. Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use. This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date February 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Low energy Hip Fracture Exclusion Criteria: - DonĀ“t meet Inclusion Criteria - Present any other synchronic fracture. - Drug allergy for drugs used for nerve blocking - Skin infection at injection site. - Contraindication due to comorbidities. - Pathologic fractures. - Cognitive impairment - Do not give his consent.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
Pain management at ER Department will be as usually with iv drugs and ultrasound guided Suprainguinal Iliac Fascia Nerve Block.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital San Carlos, Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Control after Ultrasound guided nerve block vs iv painkillers Using Visual Analogue Scale (1-No pain; 10 -worst pain) measure difference between pain during arrival at Emergency Department and 30 minutes after Ultrasound guided nerve block vs iv painkillers During Emergency Department stay (up to 12 hours)
Secondary Patient Hip Mobility with tolerable pain Range of Motion Degrees Immediately Before Discharging home assessed up to 2 weeks.
Secondary Functionality: Sit to Stand Test The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds Immediately Before Discharging home assessed up to 2 weeks.
Secondary Opioid Use Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses Immediately Before Discharging home assessed up to 2 weeks.
Secondary Patient Satisfaction Patient subjective satisfaction in a numeric scale from 1 (completely dissatisfied with pain management) to 10 (highest possible satisfaction with pain management). Immediately Before Discharging home assessed up to 2 weeks.
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