Low vs High Concentration Local Anesthesia for Hip Replacement

(HALF Trial)

Overseen By Yehoshya Gleicher, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Opioids

Disqualifiers: Outpatient THA, Alcohol, Drug dependency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery day

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using chronic opioids or have contraindications to the study medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment High Concentration Local Anesthetic Fascia Iliaca Compartment Block for hip replacement?

Research shows that the fascia iliaca compartment block is effective in reducing pain after hip and femur surgeries, and it is more effective than the '3-in-1' block in children for lower limb surgeries. However, for hip arthroscopy, it may not be better than a sham injection for pain control and can decrease muscle strength, increasing fall risk. ^{1 2 3 4 5}

Is the fascia iliaca compartment block safe for use in hip replacement surgery?

The fascia iliaca compartment block, used for pain relief in hip surgeries, is generally considered safe, but high doses of local anesthetics may pose a risk for toxicity. Some studies suggest it may decrease morphine use after surgery, but it can also reduce muscle strength and increase fall risk. ^{1 2 6 7 8}

How does the fascia iliaca compartment block treatment differ from other treatments for hip replacement?

The fascia iliaca compartment block is unique because it targets specific nerves in the hip area to provide pain relief, and it can be administered with different concentrations of local anesthetic. While it may reduce morphine use after surgery, it has been shown to be less effective than other methods for pain control and may decrease muscle strength, increasing fall risk. ^{1 2 4 7 9}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Operative Assessment

Participants undergo pre-anesthesia consultation and receive study information

At least 24 hours before surgery

1 visit (in-person)

Treatment

Participants receive either low or high concentration local anesthesia fascia iliaca block during total hip arthroplasty

Surgery day

1 visit (in-person)

Postoperative Monitoring

Participants are assessed for pain scores, quadriceps muscle weakness, and opioid consumption at multiple time points after surgery

48 hours

Multiple assessments (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Concentration Local Anesthetic Fascia Iliaca Compartment Block
• Low Concentration Local Anesthetic Fascia Iliaca Compartment Block

Trial Overview 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).

Participant Groups

Group I: Low Concentration Local Anesthetic Fascia Iliaca Compartment Block Experimental Treatment 1 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 Block Active Control 1 Intervention

Patients will be submitted to a Suprainguinal Fascia Iliaca Block with high concentration local anesthetic (Ropivacaine 0.25%)

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Findings from Research

Recent high-level randomized controlled trials indicate that fascia iliaca compartment blocks do not provide better postoperative pain relief than sham injections after hip arthroscopy surgery.

These blocks can lead to decreased quadriceps strength and increased fall risk, making them less effective and potentially harmful compared to local anesthetic injections at the surgery site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Truth about Peripheral Nerve Blocks and Hip Arthroscopy. Zhang, AL.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Truth about Peripheral Nerve Blocks and Hip Arthroscopy. [2020]

2. France pubmed.ncbi.nlm.nih.gov

Technical success of the ultrasound-guided supra-inguinal fascia iliaca compartment block in older children and adolescents for hip arthroscopy. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Suprainguinal Fascia Iliaca Compartment Block for Postoperative Analgesia in Patients Undergoing Hip and Femur Surgeries: A Retrospective Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Fascia iliaca compartment block for femoral bone fractures in prehospital care. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Anesthetic Effect of the Fascia Iliaca Compartment Block with Different Approaches on Total Hip Arthroplasty and Its Effect on Postoperative Cognitive Dysfunction and Inflammation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided fascia iliaca compartment block combined with general anesthesia for amputation in an acute myocardial infarction patient after percutaneous coronary intervention: A case report. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly: A randomized controlled clinical trial (CONSORT). [2022]