~0 spots leftby Apr 2025

Low vs High Concentration Local Anesthesia for Hip Replacement

(HALF Trial)

Recruiting in Palo Alto (17 mi)
Hd
Overseen byHermann dos Santos Fernandes, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Toronto
No Placebo Group

Trial Summary

What is the purpose of this trial?

Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

Research Team

Hd

Hermann dos Santos Fernandes, MD, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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.

Inclusion Criteria

I am having a total hip replacement surgery as an inpatient.
You are abstinent from alcohol and drugs.
I am over 21, not pregnant, and fit for surgery according to ASA standards.

Exclusion Criteria

I have not had a standard spinal anesthesia procedure.
I have been taking the equivalent of 30 mg or more of morphine daily for the last 2 weeks.
I don't have severe body structure issues or infections that prevent nerve block procedures.
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Treatment Details

Interventions

  • High Concentration Local Anesthetic Fascia Iliaca Compartment Block (Local Anesthetic)
  • Low Concentration Local Anesthetic Fascia Iliaca Compartment Block (Local Anesthetic)
Trial OverviewThe 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).
Participant Groups
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Mount Sinai HospitalToronto, Canada
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Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Patients Recruited
1,125,000+