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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of local anesthesia used during hip fracture surgeries to determine which provides better pain relief and reduces the need for painkillers post-surgery. Participants will receive either a femoral nerve block or a suprainguinal fascia iliaca block, both standard practices. This trial is ideal for adults undergoing hip fracture surgery at the University of Alberta Hospital who can receive pain relief through nerve blocks. As an unphased trial, it allows participants to contribute to enhancing pain management techniques for future patients.

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 prior data suggests that these anesthesia techniques are safe for hip fracture surgery?

Research shows that both the femoral nerve block (FNB) and the suprainguinal fascia iliaca block (SiFi) safely manage pain during hip fracture surgery.

For the femoral nerve block, studies indicate no major increase in bleeding and effective pain relief before surgery. Patients who received FNB often experienced better pain control and faster recovery after surgery.

Regarding the suprainguinal fascia iliaca block, research highlights its effectiveness in reducing pain after hip surgery. Studies have found it to be safe, with few complications.

Both anesthesia techniques are well-tolerated and commonly used in hospitals. They are neither new nor experimental, which supports their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new anesthesia techniques for hip fracture surgery because they offer targeted nerve blocks that may improve pain management and recovery. The FNB local anesthesia uses an ultrasound-guided femoral nerve block with ropivacaine, potentially offering precise pain relief with minimal impact on the rest of the body. Meanwhile, the SiFi local anesthesia employs a suprainguinal fascia iliaca block, which could provide a broader area of pain control using a different dosage and concentration of ropivacaine. These techniques aim to enhance patient comfort and reduce the need for general anesthesia, which can come with more side effects and longer recovery times.

What evidence suggests that this trial's anesthesia techniques could be effective for reducing pain in hip fracture surgery?

This trial will compare the effectiveness of femoral nerve block (FNB) and suprainguinal fascia iliaca block (SiFi) for pain management during hip fracture surgery. Research has shown that both FNB and SiFi effectively reduce pain. Studies indicate that FNB can significantly decrease pain during movement and help patients leave the hospital sooner. A Cochrane review found that FNB reduces pain 2.5 times more than standard pain control methods. Meanwhile, SiFi has been shown to reduce the need for opioids (strong painkillers) after hip surgery. A systematic review highlighted that SiFi offers better pain relief than some other methods. Both techniques are considered safe and effective for managing pain after hip fractures. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25002922

Comparison between femoral nerve block and ... PENG block and FNB are equally effective in pain relief and in reducing opioid requirements in elderly patients with intertrochanteric fractures. However, the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06862154

Comparison of the Efficiency of Femur Nerve Block and ... This study seeks to evaluate the effects of femoral nerve block (FNB) on common hip fracture types within a trauma patient population. Specifically, we compared ...

3. annemergmed.com annemergmed.com/article/S0196-0644%25252824%25252900036-2/fulltext

Peripheral Nerve Blocks in the Preoperative Management ... We conducted a network meta-analysis to evaluate the comparative efficacy of peripheral nerve block methods for preoperative pain management of hip fractures.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11237263/

Femoral nerve blocks versus standard pain control for hip ... In a recent Cochrane review and meta-analysis of 49 studies with 3,061 participants, femoral nerve blocks were found to reduce pain with movement by 2.5-fold (0 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11204338/

Peripheral Nerve Blocks for Hip Fractures - PMC A retrospective study showed a significantly shorter length of stay and lower pain scores on postoperative days 2 and 3 in hip fracture patients ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34472236/

Safety of Femoral Nerve Blockade for Hip Fractures inAdult ... Results: We found no significant difference in the number of major bleeding events between groups (47.4% vs. 54.0%, P = 0.84). Degree of pain measured 3 and 12 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02450045

NCT02450045 | Pre-op Femoral Nerve Block for Hip Fracture Our study will look at use of a nerve block to manage pain before patients have their operation. A nerve block provides local pain relief without requiring ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138321006331

Early recovery of basic mobility under femoral nerve block ... Previous studies have shown better pain reduction utilizing femoral nerve block (FNB) in patients who underwent hip fracture surgery.