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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures; Pain, Acute; Ultrasound Therapy; Complications
• Intervention / Treatment: Procedure: Ultrasound guided Suprainguinal Iliac Fascia Nerve Block.

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Hip Mobility with tolerable pain	Range of Motion Degrees	Immediately Before Discharging home assessed up to 2 weeks.
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.
Opioid Use	Quantity of Opioid drugs consumed during Hospital stay expressed in Morphine equivalent doses	Immediately Before Discharging home assessed up to 2 weeks.
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.

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Investigators: Principal Investigator: Borja Alcobía-Díaz, MD, PhD, Clinical Assistant

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Hip Fractures Pain Ultrasound nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Disease Attributes; Femoral Fractures; Hip Injuries; Emergencies; Fractures, Bone; Hip Fractures; Acute Pain
• Other Study ID Numbers: 22/027-EC_X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Email Contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No