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

Trial Summary

What is the purpose of this trial?

This trial is testing if a numbing injection near the collarbone can better control pain in children aged 4-12 who have specific elbow fractures and need surgery. The injection blocks pain signals from the arm to the brain. The goal is to see if this method reduces the need for pain medicine after surgery.

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 data supports the idea that Regional Anesthesia for Broken Arm is an effective treatment?

The available research shows that Regional Anesthesia, specifically the Infraclavicular Nerve Block, is effective in reducing pain after surgery for a broken arm. One study found that this type of anesthesia helps reduce pain after surgery for a broken wrist, which is part of the arm. This suggests it can be effective for other arm injuries too. Additionally, a review comparing different methods of anesthesia for the arm suggests that the Infraclavicular Block has several advantages over other techniques, making it a good choice for pain management. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Infraclavicular Nerve Block for a 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 distal radial fracture, when compared to general anesthesia. ^{1 2 3 4 5}

What safety data is available for infraclavicular nerve block (ICB) used in regional anesthesia?

The infraclavicular brachial plexus block (ICB) is considered a safe technique for upper-limb anesthesia. Studies have shown that both single-stimulation and double-stimulation ICB are safe and effective methods for regional anesthesia. The technique has been systematically reviewed and compared to other brachial plexus blocks, highlighting its advantages and safety profile. ^{1 2 3 5 6}

Is the infraclavicular brachial plexus block (ICB) safe for use in humans?

The infraclavicular brachial plexus block (ICB) is considered a safe technique for providing anesthesia to the upper limb, as noted in studies comparing it to other methods. ^{1 2 3 5 6}

Is the treatment in the trial 'Regional Anesthesia for Broken Arm' promising?

Yes, the treatment, known as infraclavicular brachial plexus block, is promising because it can effectively reduce pain after surgery for a broken arm. ^{1 2 3 4 5}

How does regional anesthesia for a broken arm differ from other treatments?

Regional anesthesia for a broken arm, specifically using the infraclavicular brachial plexus block, is unique because it targets the nerves in the shoulder area to numb the entire arm, potentially offering better pain control after surgery compared to general anesthesia. This method can reduce the need for additional pain medications after surgery. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Resident versus staff anesthesiologist performance: coracoid approach to infraclavicular brachial plexus blocks using a double-stimulation technique. [2019]

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

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. [2018]

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

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A comparison of a single-stimulation lateral infraclavicular plexus block with a triple-stimulation axillary block. [2019]