60 Participants Needed

Low vs High Concentration Local Anesthesia for Hip Replacement

(HALF Trial)

Hd
YG
Overseen ByYehoshya Gleicher, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of anesthesia for individuals undergoing hip replacement surgery. The goal is to determine if low concentration anesthesia can control pain as effectively as high concentration anesthesia, but without causing muscle weakness. Individuals scheduled for hip replacement surgery in a hospital, who do not have a history of heavy opioid use, might be suitable candidates for this trial. Participants will receive either a high or low concentration of local anesthesia (fascia iliaca compartment block) to evaluate which provides the best pain relief without affecting muscle strength. As an unphased trial, this study allows participants to contribute to important research that could enhance anesthesia options for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both high and low concentration local anesthetics are generally safe for pain relief in hip replacement surgeries. Studies have found that high concentration anesthetics, such as ropivacaine, effectively reduce pain but can sometimes cause muscle weakness, particularly in the quadriceps, the large muscle on the front of the thigh.

Low concentration anesthetics also demonstrate promising results. They provide effective pain relief while minimizing significant muscle weakness, allowing patients to maintain better muscle strength after surgery. Evidence from other procedures, like epidurals, suggests that low concentration anesthetics can control pain safely and effectively without causing much muscle weakness.

Overall, previous studies have used both types of local anesthetics safely, with low concentrations offering the added benefit of preserving muscle strength. This makes them a potentially safer option for those concerned about muscle weakness after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of using different concentrations of ropivacaine in fascia iliaca compartment blocks for hip replacement surgery. Unlike standard anesthesia techniques, which typically use a one-size-fits-all concentration, this trial investigates both high (0.25%) and low (0.075%) concentrations of ropivacaine to see which provides better pain relief and fewer side effects. By fine-tuning the anesthetic concentration, the goal is to optimize patient outcomes, potentially reducing recovery time and enhancing comfort post-surgery. This approach could lead to more personalized pain management strategies, aligning with the broader trend in medicine towards individualized care.

What evidence suggests that this trial's treatments could be effective for postoperative analgesia in hip replacement surgery?

This trial will compare the effects of high versus low concentration local anesthetic fascia iliaca compartment blocks (FICB) for hip replacement surgery. Research has shown that an FICB can reduce the need for opioids after surgery. However, high doses of local anesthetics may cause muscle weakness. Studies have found that lower doses can still provide effective pain relief without this side effect. This has been particularly noted in surgeries related to childbirth. Overall, lower doses might offer the same pain relief as higher doses but with fewer side effects, such as muscle weakness.14678

Who Is on the Research Team?

Hd

Hermann dos Santos Fernandes, MD, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Low Concentration Local Anesthetic Fascia Iliaca Compartment BlockExperimental Treatment1 Intervention
Group II: High Concentration Local Anesthetic Fascia Iliaca Compartment BlockActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Recruited
1,125,000+

Published Research Related to This Trial

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

Citations

90% minimum effective concentration of ropivacaine for ...Current evidence suggests that effective analgesia with S-FICB necessitates the administration of relatively high volumes of local anesthetic, ...
Fascia iliaca compartment block for postoperative pain ...FICB significantly reduces the total analgesic consumption up to 48 h; however, it is not effective in reducing post-operative pain, nausea and vomiting.
Pain Control After Total Hip Arthroplasty: A Randomized ...This randomized trial shows that a fascia iliaca compartment block does not improve functional performance and does not decrease pain levels or narcotic usage ...
Low Concentration Local Anesthesia Fascia Iliaca Block for ...FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available ...
The efficacy and safety of peripheral nerve blocks for ...In this meta-analysis, the infrainguinal fascia iliaca compartment block (I_FICB) ranked best in reducing both dynamic and static pain scores ...
The efficacy and safety of peripheral nerve blocks for ...In this meta-analysis, the infrainguinal fascia iliaca compartment block (I_FICB) ranked best in reducing both dynamic and static pain scores ...
Hip arthroplasty with low concentration local anesthetic ...Low concentration LA (LCLA) epidurals as using Bupivacaine or Ropivacaine ≤0.1 % were shown to maintain an effective level of analgesia and avoid important ...
Review article The effect of fascia iliaca compartment block ...This meta-analysis indicated that FIB could reduce the incidence of POD in elderly patients undergoing hip surgery without preoperative cognitive impairment.
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