Regional Anesthesia for Broken Arm

Overseen By Johanthan You, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Disqualifiers: Open fractures, Concomitant injuries, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore better pain management for children after surgery on a broken arm, specifically focusing on a closed lateral condyle fracture. Researchers seek to determine if an infraclavicular nerve block (a form of regional anesthesia) administered before surgery can reduce the need for opioids, such as oxycodone, for pain relief. Children with this specific arm fracture who will undergo a particular type of surgery to fix it might be eligible to join. The study aims to improve satisfaction with pain control and reduce opioid use by comparing two groups: one receiving the nerve block and the other following the standard pain management protocol. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, all patients will receive standard oxycodone solution prescriptions post-operatively.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, all patients will receive standard oxycodone for pain after surgery.

What is the safety track record for the infraclavicular nerve block and the standard preoperative protocol?

Research shows that the infraclavicular nerve block is generally safe for managing pain after arm surgeries. A previous study found this type of anesthesia effectively reduced pain for patients with arm fractures. Although it takes a bit longer to perform, it has proven effective for pain relief.

This treatment is currently in a Phase 4 trial, indicating it has been tested in earlier stages and is considered quite safe. Doctors perform the infraclavicular nerve block with the help of an ultrasound, which allows them to accurately target the nerves. While specific data does not show improved safety with ultrasound, this method is commonly used to enhance accuracy and potentially reduce risks.

Overall, the infraclavicular nerve block is well-tolerated, with few reports of serious side effects. Prospective trial participants should know that research supports this treatment, and it has been used safely in many patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional treatments for a broken arm, which typically involve immobilization with a cast or splint and oral pain medications, the infraclavicular nerve block directly targets pain by numbing the nerves in the arm. This method uses ropivacaine, an anesthetic, delivered precisely through ultrasound guidance. Researchers are excited about this approach because it could offer more immediate and effective pain relief compared to oral medications, with potentially fewer systemic side effects. Additionally, the precision of nerve blocks might enhance recovery by allowing patients to begin rehabilitation exercises sooner.

What evidence suggests that the infraclavicular nerve block is effective for post-operative pain control in pediatric patients with broken arms?

Research has shown that an infraclavicular nerve block, a type of regional anesthesia, effectively reduces pain after arm surgeries, including fractures. In this trial, participants in the infraclavicular regional block arm will receive this anesthesia. Studies have found that this method provides better pain relief compared to other nerve blocks, such as supraclavicular nerve blocks, for managing pain in upper limb surgeries. Specifically, some cases demonstrated improved pain relief after surgeries for broken arm bones. This approach may reduce the need for opioid medications by offering better pain control. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children with a specific type of broken arm (isolated lateral condyle humerus fracture) that needs surgery to fix it. They must not have other injuries, allergies to ropivacaine or oxycodone, open fractures, swelling needing hospital stays after surgery, or conditions affecting their ability to rate pain using facial expressions.

Inclusion Criteria

I had surgery to fix a broken bone with pins.

I have a fracture in the outer part of my elbow bone.

My elbow fracture is classified as a type II or III lateral condyle with more than 2mm displacement.

Exclusion Criteria

You have other injuries or health problems at the same time.

You have a cognitive impairment that prevents you from using the Faces Pain Scale-Revised.

I have had fractures due to my disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preoperative

Participants are randomized into treatment groups and receive either an infraclavicular nerve block or standard preoperative protocol

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo open reduction and percutaneous pinning, followed by pain management in the PACU

1 day

1 visit (in-person)

Postoperative Monitoring

Pain levels are assessed using the Wong-Baker FACES scale, and parents complete satisfaction questionnaires and medication logs

1 week

2 visits (1 in-person, 1 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain management and side effects

7-10 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Infraclavicular Nerve Block

Trial Overview The study compares two ways to manage pain after arm fracture surgery in kids. One group gets a nerve block before surgery; the other follows standard care. Both get oxycodone afterwards. Pain and satisfaction are checked using scales and questionnaires over about one week.

How Is the Trial Designed?

Group I: Infraclavicular Regional Block Experimental Treatment 1 Intervention

This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.

Group II: Puncture Wound Placebo Group 1 Intervention

This group is given the same puncture wound and dressing given to the experimental group.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Infraclavicular blockade (ICB) is a safe and effective method for providing surgical anaesthesia of the lower arm, showing comparable efficacy to other brachial plexus blocks (BPBs) in a review of 15 studies with 1020 participants.

ICB significantly reduces the likelihood of tourniquet pain during surgery and provides more reliable sensory block of the musculocutaneous and axillary nerves compared to a single-injection axillary block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Chin, KJ., Singh, M., Velayutham, V., et al.[2018]

Infraclavicular blockade (ICB) is as safe and effective as other brachial plexus blocks for providing regional anaesthesia for lower arm surgery, based on a systematic review of 22 studies involving 1732 participants.

ICB has advantages over other techniques, including a lower likelihood of tourniquet pain and more reliable sensory block of the musculocutaneous nerve compared to single-injection axillary blocks, along with a faster performance time than multi-injection techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Chin, KJ., Alakkad, H., Adhikary, SD., et al.[2022]

Infraclavicular brachial plexus block (ICB) can be performed safely and effectively by resident anesthesiologists, with a success rate of 90%, which is comparable to the 93% success rate achieved by experienced staff anesthesiologists.

While residents took longer to perform the block (5.8 minutes) compared to staff (3.9 minutes), the overall efficacy and safety were similar, suggesting that ICB should be included in anesthesiology residency training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resident versus staff anesthesiologist performance: coracoid approach to infraclavicular brachial plexus blocks using a double-stimulation technique. Minville, V., Asehnoune, K., Chassery, C., et al.[2019]

In a study of 52 patients undergoing distal radial fracture fixation, regional anesthesia (infraclavicular nerve block) provided significantly better acute pain relief compared to general anesthesia, with lower pain scores at multiple time points post-surgery.

Patients receiving regional anesthesia also reported higher satisfaction, experienced less nausea and vomiting, and required less morphine in the post-anesthetic care unit, suggesting it may be a safer and more effective option for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. Wong, SS., Chan, WS., Fang, C., et al.[2021]

Infraclavicular blockade (ICB) is a safe and effective technique for providing surgical anaesthesia of the lower arm, showing comparable efficacy to other brachial plexus blocks (BPBs) in a review of 15 studies with 1020 participants.

ICB significantly reduces the likelihood of tourniquet pain during surgery and provides more reliable sensory block of the musculocutaneous and axillary nerves compared to a single-injection axillary block, although it has a longer onset time for sensory blockade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Chin, KJ., Singh, M., Velayutham, V., et al.[2018]

The single-stimulation infraclavicular brachial plexus block (ICB) is quicker to perform than the triple-stimulation axillary block (AxB), taking an average of 2.5 minutes compared to 6.0 minutes, making it a more efficient option for anesthesia in hand and forearm surgeries.

Both techniques have similar success rates in achieving complete nerve blocks (90% for ICB vs. 88% for AxB), indicating that ICB is just as effective as AxB for providing anesthesia, while also being easier and faster to administer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of a single-stimulation lateral infraclavicular plexus block with a triple-stimulation axillary block. Deleuze, A., Gentili, ME., Marret, E., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11175878/

A meta-analysis of randomized controlled studies - PMC Infraclavicular nerve block may be superior to supraclavicular nerve block for the analgesia of distal arm surgeries but needs increased block performance time.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217371027

Ultrasound-guided infraclavicular brachial plexus block The purpose of this study was to test the feasibility of seeing individual nerves of the brachial plexus and directing the block needle to these nerves with ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2024/10250/infraclavicular_versus_supraclavicular_nerve_block.47.aspx

Infraclavicular versus supraclavicular nerve block for upper Infraclavicular nerve block may be superior to control the analgesia for upper limb surgeries than supraclavicular nerve block.

4. withpower.com withpower.com/trial/phase-4-fractures-bone-8-2019-021bb

Regional Anesthesia for Broken Arm Research shows that the infraclavicular nerve block, a type of regional anesthesia, can effectively reduce pain after surgery for arm fractures, such as a ...

5. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01044-4

Infraclavicular nerve block reduces postoperative pain after ... Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation.

6. asra.com asra.com/news-publications/asra-updates/blog-landing/legacy-b-blog-posts/2019/08/07/infraclavicular-block

Infraclavicular Block Currently, there is no RCT data regarding improved safety outcomes with US guidance for peripheral nerve blocks, as intravascular injection ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00724035

Ultrasound-Guided Axillary or Infraclavicular Nerve Block ... A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same ...