Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05403073
Collaborator
(none)
72
2
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Nerve Blocking

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

Active Comparator: Ultrasound Nerve blocking

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

Outcome Measures

Primary Outcome Measures

  1. Pain Control after Ultrasound guided nerve block vs iv painkillers [During Emergency Department stay (up to 12 hours)]

    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

Secondary Outcome Measures

  1. Patient Hip Mobility with tolerable pain [Immediately Before Discharging home assessed up to 2 weeks.]

    Range of Motion Degrees

  2. Functionality: Sit to Stand Test [Immediately Before Discharging home assessed up to 2 weeks.]

    The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds

  3. Opioid Use [Immediately Before Discharging home assessed up to 2 weeks.]

    Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses

  4. Patient Satisfaction [Immediately Before Discharging home assessed up to 2 weeks.]

    Patient subjective satisfaction in a numeric scale from 1 (completely dissatisfied with pain management) to 10 (highest possible satisfaction with pain management).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Low energy Hip Fracture
Exclusion Criteria:
  • Don´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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital San Carlos, Madrid

Investigators

  • Principal Investigator: Borja Alcobía-Díaz, MD, PhD, Clinical Assistant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Borja Alcobía-Díaz MD, PhD, MD, PhD, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT05403073
Other Study ID Numbers:
  • 22/027-EC_X
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Borja Alcobía-Díaz MD, PhD, MD, PhD, Principal Investigator, Hospital San Carlos, Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022