Nerve Block for Pain Control After Broken Bone Surgery

Overseen By Stuart A Aitken, MBChB MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaineGeneral Health

Disqualifiers: Multiple fractures, Cognitive impairment, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to control pain after surgery for a broken ankle or wrist. It compares two methods: one uses a peripheral nerve block (an injection to numb a specific area) with sedation, and the other uses general anesthesia (which puts the patient to sleep) possibly followed by a nerve block. The goal is to determine which method provides better pain relief and reduces the need for pain medication. Individuals with an isolated fracture requiring outpatient surgery within two weeks of injury might be suitable candidates. As an unphased trial, this study allows participants to contribute to research that could enhance post-surgical pain management for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

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

Research shows that peripheral nerve blocks are generally safe and well-tolerated. One study found they can lower the risk of developing long-term pain after surgery by 42%. Another review highlights their effectiveness in managing post-surgical pain, reducing the need for additional pain medication. Safety considerations suggest that nerve blocks can reliably complement or replace general anesthesia, enhancing pain control during and after surgery.

General anesthesia, widely used and well-understood, involves inducing sleep for surgery and is typically safe when administered by trained professionals. While it can cause side effects like nausea or a sore throat, these are usually temporary.

In summary, both peripheral nerve blocks and general anesthesia have strong safety records. Most patients handle them well with few serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using peripheral nerve blocks (PNB) for pain control after broken bone surgery because it offers a targeted approach to pain management. Unlike general anesthesia, which affects the whole body, PNB delivers local anesthesia directly to the nerve near the injury site, using ultrasound guidance. This method can minimize the need for systemic pain medications, which often come with side effects like nausea and drowsiness. Additionally, including dexamethasone with bupivacaine in the PNB may prolong the pain relief duration, providing patients with a more comfortable recovery.

What evidence suggests that this trial's treatments could be effective for pain control after broken bone surgery?

Research has shown that peripheral nerve blocks, a treatment under study in this trial, effectively reduce pain after surgery. They can decrease the need for opioid painkillers, which often cause side effects. One study found that these nerve blocks provide excellent pain relief in the first 8 to 12 hours after surgery for ankle or wrist fractures. Another source confirmed that these blocks help lower immediate post-surgery pain and reduce opioid use. In this trial, participants receiving the peripheral nerve block will receive a combination of bupivacaine (a pain relief drug) and dexamethasone (an anti-inflammatory), which studies suggest enhances the blocks' effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for outpatients with a recent (within 2 weeks) isolated ankle or distal radius fracture needing surgery. Participants must be able to follow-up via telephone and have no cognitive impairments, multiple fractures, inpatient status, or contraindications to nerve blocks.

Inclusion Criteria

My injury happened less than 2 weeks ago.

I need surgery for a broken bone that is the only injury.

I am not currently hospitalized.

Exclusion Criteria

Unable to comply with follow-up

I am currently hospitalized.

No means of telephone contact

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with either preoperative PNB or GA with 'as needed' postoperative PNB

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for pain and analgesic consumption in the first 72 hours post-surgery

3 days

Telephone follow-ups at 12, 24, 48, and 72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Nerve Block

Trial Overview The study compares pain relief strategies after fracture surgery: one group receives peripheral nerve block with sedation during surgery, while the other gets general anesthesia followed by a nerve block only if needed for pain after surgery.

How Is the Trial Designed?

Group I: Peripheral Nerve Block Active Control 1 Intervention

Participants will receive an ultrasound-guided, single shot PNB using 30ml 0.5% bupivacaine with 10mg dexamethasone. The anatomic location of the block will be determined by the anesthesiologist and will vary according to fracture location and anticipated surgical approaches. Intraoperative sedation will be used at the discretion of the anesthetic team.

Group II: General Anesthesia +/- PNB Active Control 1 Intervention

GA will be administered in the operating room by a nurse anesthetist, with support from the anesthesiologist. GA will be induced with propofol and fentanyl and maintained with sevoflurane or desflurane and fentanyl. Doses will be determined by the anesthesiology team.

Peripheral Nerve Block is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management

Approved in United States as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management
• Acute pain management

Approved in Canada as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management

Approved in Japan as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management

Who Is Running the Clinical Trial?

MaineGeneral Health

Lead Sponsor

Trials

2

Recruited

200+

Published Research Related to This Trial

In a study of 93 patients undergoing surgery for tibia and ankle fractures, those who received peripheral nerve blocks (PNBs) reported significantly higher satisfaction with pain management and better quality of recovery in the first 24 hours post-surgery.

Patients receiving PNBs experienced less severe pain and a greater overall perception of pain relief compared to those who only received systemic analgesia, indicating that PNBs can enhance postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Regional Anesthesia Improve the Quality of Postoperative Pain Management and the Quality of Recovery in Patients Undergoing Operative Repair of Tibia and Ankle Fractures? Elkassabany, N., Cai, LF., Mehta, S., et al.[2015]

A systematic review of six studies involving 537 participants found no significant advantage of peripheral nerve block over general anesthesia in terms of functional recovery after orthopedic upper limb surgery.

The evidence quality was low to very low, indicating that more research is needed to determine the long-term effects of peripheral nerve block on recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional recovery with peripheral nerve block versus general anesthesia for upper limb surgery: a systematic review. Héroux, J., Bessette, PO., Belley-Côté, E., et al.[2023]

Peripheral nerve blocks, particularly adductor canal blocks, are effective for pain management in knee orthopedic surgeries, leading to reduced pain and lower narcotic use.

These blocks help maintain quadriceps function, promoting early postoperative mobility and physical therapy, with a low risk of serious complications ranging from 0% to 3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Blocks for Surgery About the Knee. Howell, R., Hill, B., Hoffman, C., et al.[2022]

Peripheral nerve blocks provide effective postoperative pain relief after lower limb surgeries, such as total knee prosthesis and hallux valgus surgery, and are superior to morphine-controlled analgesia.

Using peripheral nerve blocks reduces the need for opioids, minimizing their side effects and avoiding complications associated with epidural analgesia, such as urinary retention and the need for continuous monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Regional analgesia after lower limb orthopaedic surgery]. Godfroid, N., Lecoq, JP., Remy, B., et al.[2022]

In a study involving 6950 patients who received peripheral nerve blocks, serious complications were rare, with only 0.5% requiring neurologic assessment and an incidence of nerve injury at 0.4 per 1000 blocks.

The incidence of systemic local anesthetic toxicity was also low at 0.98 per 1000 blocks, suggesting that peripheral nerve blockade is a safe procedure with minimal risk of severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Barrington, MJ., Watts, SA., Gledhill, SR., et al.[2022]

Peripheral nerve blocks are a safe and effective method for managing early postoperative pain, which is crucial for improving patient outcomes such as satisfaction and reducing hospital costs.

These nerve blocks can serve as an alternative or supplement to traditional pain management, especially for patients who may not tolerate strong narcotics or general anesthesia, including the elderly and those with heart or lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Blocks in Foot and Ankle Surgery. Fraser, TW., Doty, JF.[2022]

Peripheral nerve blocks (PNB) can effectively reduce procedural pain and avoid harmful effects of local anesthetics on target tissues, enhancing patient comfort during procedures.

The risks associated with PNBs, such as local nerve damage and systemic toxicity, can be minimized through careful injection techniques and a thorough understanding of the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional Anesthesia for Orthobiologic Procedures. Khadavi, M., Rehor, D., Roney, A., et al.[2022]

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]

A study involving 64 healthcare professionals at Black Lion Hospital revealed that while there is a strong belief in the importance of peripheral nerve blocks for pain management, nearly half (48%) do not perform them regularly due to a lack of skills and training.

The study found a significant link between formal training in peripheral nerve blocks and the frequency of their use, suggesting that improving training could enhance their application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. Zewdie, A., Debebe, F., Azazh, A., et al.[2022]

Recent studies highlight the growing use of peripheral nerve blocks for lower limb surgery, which offer prolonged pain relief and high patient satisfaction with minimal side effects.

Advancements in imaging techniques, such as ultrasound, have enhanced the effectiveness and safety of these nerve blocks, making them a preferred option over central nerve blocks, especially in patients on anticoagulants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower extremity nerve blocks. Taboada, M., Atanassoff, PG.[2019]

Local and regional nerve blocks are effective for managing postoperative pain, especially in trunk surgeries, providing a good alternative to epidural analgesia.

The rising use of low molecular weight heparin has led to an increased preference for peripheral nerve blocks in patients undergoing lower limb surgeries, enhancing pain control while minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and regional block in postoperative pain control. Peng, PW., Chan, VW.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456737/

Nerve Blocks for Post-Surgical Pain Management: A Narrative ... Nerve blocks show great promise as effective alternatives for managing post-surgical pain. They can reduce the need for opioids and their side effects.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225003447

Association of peripheral nerve blocks with increased ... Although single injection peripheral nerve blocks were effective in reducing immediate postoperative pain and opioid consumption, they were associated with ...

3. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(21)00007-6/fulltext

Peripheral nerve block anaesthesia and postoperative pain ... The AnAnkle Trial was designed to assess the postoperative pain profile of PNB anaesthesia compared with spinal anaesthesia (SA).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05391464

Nerve Block for Pain Control After Fracture Surgery For patients undergoing ORIF for ankle or distal radius fractures, successfully administered PNB can provide excellent pain relief in the first 8 to 12 hours ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37512113/

A Comparative Analysis of Pain Control Methods after ... This study aimed to compare the postoperative pain control efficacy of peripheral nerve blocks with ropivacaine combined with dexamethasone/epinephrine.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10239283/

A Comprehensive Review on the Efficacy of Nerve Blocks in ... This article review analyzed the effectiveness of utilizing nerve blocks to reduce the need for postoperative anesthetic and analgesic medications.

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40264

Peripheral Nerve Blocks and Procedures for Chronic Pain A nerve block is a form of regional anesthesia attempts to inhibit impulse transmission distally in a nerve terminal, thus terminating the pain signal perceived ...

8. apsf.org apsf.org/article/safety-considerations-in-peripheral-nerve-blocks/

Safety Considerations in Peripheral Nerve Blocks Peripheral nerve blocks (PNB) are safe and effective alternatives or supplements to general anesthesia. They may improve pain control both during and after ...