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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after spinal anesthesia
Awards & highlights
HALF Trial 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.Check my eligibility
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).See study design
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.
HALF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a total hip replacement surgery as an inpatient.
Select...
I am over 21, not pregnant, and fit for surgery according to ASA standards.
HALF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours after spinal anesthesia
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours after spinal anesthesia
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quadriceps muscle strenght
Secondary outcome measures
Opioid consumption
Pain scores
HALF 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
690 Previous Clinical Trials
1,019,583 Total Patients Enrolled
Hermann dos Santos Fernandes, MD, PhDPrincipal InvestigatorUniversity of Toronto
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still space available to join this medical experiment?
"Affirmative. According to clinicaltrials.gov, this medical research has been open for participant recruitment since October 23rd 2023 and was last updated on 10/22/2023. Sixty participants are being sought from one study location."
Answered by AI
How many individuals have enrolled in this research project?
"Affirmative. Information available from clinicaltrials.gov suggests that this trial, first published on October 23rd 2023, is actively looking for volunteers to enroll. There are 60 positions open across 1 medical centre."
Answered by AI
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