NCT05403073

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

February 25, 2022

Last Update Submit

June 1, 2022

Conditions

Keywords

Hip Fractures Pain Ultrasound nerve block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient Hip Mobility with tolerable pain

    Immediately Before Discharging home assessed up to 2 weeks.

  • Functionality: Sit to Stand Test

    Immediately Before Discharging home assessed up to 2 weeks.

  • Opioid Use

    Immediately Before Discharging home assessed up to 2 weeks.

  • Patient Satisfaction

    Immediately Before Discharging home assessed up to 2 weeks.

Study Arms (2)

No Nerve Blocking

NO INTERVENTION

Pain management at ER Department will be as usually with iv drugs and 3 kilogram soft traction.

Ultrasound Nerve blocking

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.

Interventions

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

Ultrasound Nerve blocking

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Low energy Hip Fracture

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip FracturesAcute Pain

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Borja Alcobía-Díaz, MD, PhD

    Clinical Assistant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Borja Alcobía-Díaz, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

February 25, 2022

First Posted

June 3, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

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