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Local Anesthetic

Low vs High Concentration Local Anesthesia for Hip Replacement (HALF Trial)

N/A
Recruiting
Led By Hermann dos Santos Fernandes, MD, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing primary THA in the inpatient setting
Non-pregnant patients older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-IV
Must not have
Not submitted to the standardized spinal anesthesia technique
Chronic opioid use of 30 mg or more of oral morphine equivalent, per day, for the last 2 consecutive weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after spinal anesthesia
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if using low-concentration local anesthetics for hip replacement surgery reduces pain while preserving muscle strength.

Who is the study for?
This trial is for adults over 21 years old who are having a primary total hip arthroplasty (hip replacement) in an inpatient setting. They should not be pregnant, have no severe anatomical issues, infections, or allergies to the study's medications, and must not be dependent on alcohol or drugs.
What is being tested?
The study tests if low concentration local anesthetic (LCLA) used in fascia iliaca compartment block provides good pain control without causing muscle weakness after hip surgery compared to high concentration local anesthetic (HCLA).
What are the potential side effects?
Possible side effects include temporary numbness or weakness in the leg due to nerve blockage. There may also be typical risks associated with anesthesia such as nausea or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a total hip replacement surgery as an inpatient.
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I am over 21, not pregnant, and fit for surgery according to ASA standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a standard spinal anesthesia procedure.
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I have been taking the equivalent of 30 mg or more of morphine daily for the last 2 weeks.
Select...
I don't have severe body structure issues or infections that prevent nerve block procedures.
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I am not allergic or unable to take Mepivacaine, Fentanyl, Dexamethasone, Ondansetron, Acetaminophen, Celecoxib, or Hydromorphone.
Select...
I needed to be put under general anesthesia during surgery.
Select...
I am having a hip replacement surgery as an outpatient.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours after spinal anesthesia
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours after spinal anesthesia for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quadriceps muscle strenght
Secondary study objectives
Opioid consumption
Pain scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low Concentration Local Anesthetic Fascia Iliaca Compartment BlockExperimental Treatment1 Intervention
Patients will be submitted to a Suprainguinal Fascia Iliaca Block with low concentration local anesthetic (Ropivacaine 0.075%)
Group II: High Concentration Local Anesthetic Fascia Iliaca Compartment BlockActive Control1 Intervention
Patients will be submitted to a Suprainguinal Fascia Iliaca Block with high concentration local anesthetic (Ropivacaine 0.25%)

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
719 Previous Clinical Trials
1,042,492 Total Patients Enrolled
Hermann dos Santos Fernandes, MD, PhDPrincipal InvestigatorUniversity of Toronto
~30 spots leftby Nov 2025
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