Local Anesthesia for Hip Fracture Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Contraindication, Refuses consent, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

106 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Regional Anesthesia, Nerve Blocks, Neuraxial Anesthesia, Peripheral Nerve Blocks, Intravenous Regional Anesthesia, Spinal Anesthesia, Epidural Anesthesia for hip fracture surgery?

Research shows that regional anesthesia, including peripheral nerve blocks and spinal anesthesia, can reduce complications and improve patient satisfaction compared to general anesthesia. Additionally, peripheral nerve blocks are beneficial for pain management and may reduce the risk of confusion and heart issues after hip fracture surgery. ^{1 2 3 4 5}

Is local anesthesia for hip fracture surgery safe?

Peripheral nerve blocks, a type of local anesthesia, are increasingly used for hip fractures and are generally considered safe, though there are some risks like overdosage and nerve damage. Studies suggest that regional anesthesia, including nerve blocks, may have fewer adverse events compared to general anesthesia, and can even reduce mortality in high-risk patients. ^{6 7 8 9 10}

How is regional anesthesia different from other treatments for hip fracture surgery?

Regional anesthesia, like nerve blocks, is unique because it targets specific nerves to numb the area around the hip fracture, potentially offering better pain control and fewer side effects than general anesthesia. It can be particularly beneficial for patients with other health issues, as it may provide stable conditions during surgery and effective pain relief afterward without the complications associated with general anesthesia. ^{3 11 12 13 14}

Eligibility Criteria

This trial is for adults over 18 who are having hip fracture surgery at the University of Alberta Hospital and can receive multimodal analgesia with a nerve block. It's not suitable for those who have conditions that make nerve blocks unsafe or those who don't consent to this type of anesthesia.

Inclusion Criteria

I can receive different types of pain management, including nerve block.

I am having hip fracture surgery at the University of Alberta Hospital.

Exclusion Criteria

I do not consent to a nerve block procedure.

I cannot have a nerve block due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Anesthesia

Participants receive either femoral nerve block or suprainguinal fascia iliaca block preoperatively

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores and opioid utilization post-surgery

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Regional Anesthesia

Trial Overview The study compares two local/regional anesthesia techniques in hip fracture surgeries: femoral nerve block (FNB) and suprainguinal fascia iliaca block (SiFi). Patients will be randomly assigned to one technique, focusing on pain levels and postoperative painkillers needed.

Participant Groups

Group I: SIFI local anesthesia Experimental Treatment 1 Intervention

Subjects randomized to the SiFi arm will have an ultrasound-guided suprainguinal fascia iliaca single shot block performed preoperatively in the anesthesia block room with 40ml of 0.2% ropivacaine local anesthetic. This will be reduced to 30 ml in patients under 60 kg.

Group II: FNB local anesthesia Active Control 1 Intervention

Subjects randomized to the FNB arm will have an ultrasound-guided femoral nerve single shot block performed preoperatively in the anesthesia block room with 20ml of 0.5% ropivacaine local anesthetic. This will be reduced to 15ml in patients under 60 kg.

Regional Anesthesia is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in United States as Regional Anesthesia for:

• Ankle fracture pain control
• Childbirth
• Prostate surgery
• Knee surgery
• Shoulder surgery
• Chronic pain management

Approved in Canada as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in Japan as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in China as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in Switzerland as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

Peripheral nerve blocks are becoming more popular than general anesthesia due to their advantages, but they still carry risks such as overdose and potential nerve damage.

Techniques involving nerve stimulators, anatomical landmarks, and careful selection of needles and anesthetic solutions can enhance the success of these blocks while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. Bruelle, P., Mangin, R., Lalourcey, L., et al.[2013]

In a study of 60 patients undergoing knee replacement, combined femoral (3-in-1) and sciatic nerve blocks provided better pain control at 24 hours post-surgery compared to epidural blockade, with significantly lower visual analogue scale (VAS) pain scores.

Both analgesic techniques resulted in low total morphine usage and high patient satisfaction, indicating that combined nerve blocks are a safe and effective alternative to epidural analgesia for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Davies, AF., Segar, EP., Murdoch, J., et al.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Peripheral Nerve Block and Spinal Anesthesia in Terms of Postoperative Mortality and Walking Ability in Elderly Hip Fracture Patients - A Retrospective, Propensity-Score Matched Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Trends in the Use of Regional Anesthesia: Neuraxial and Peripheral Nerve Blocks. [2019]

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

Peripheral Nerve Block as a Supplement to Light or Deep General Anesthesia in Elderly Patients Receiving Total Hip Arthroplasty: A Prospective Randomized Study. [2018]

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

Orthopaedic anesthesia - part 2. Common techniques of regional anesthesia in orthopaedics. [2008]

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

Peripheral Nerve Blocks for Hip Fractures: A Cochrane Review. [2019]

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

Peripheral Nerve Blocks and Potentially Attributable Adverse Events in Older People with Hip Fracture: A Retrospective Population-based Cohort Study. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. [2013]

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

Hip fracture mortality: is it affected by anesthesia techniques? [2021]

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

It's Never Just a Block: An Analysis of Regional Anesthesia Closed Claims. [2020]

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

Ultrasound-guided lumbar selective nerve root block plus T12 paravertebral and sacral plexus block for hip and knee arthroplasty: Three case reports. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

[Combined posterior lumbar plexus and sacral block for emergency surgery to treat hip fracture]. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Anesthesia selection on Post-Op Pain Management in Operatively treated Hip Fractures. [2023]

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

Ultrasound-guided, direct suprainguinal injection for fascia iliaca block for total hip arthroplasty: A retrospective study. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. [2018]