What side effects are associated with this type of intervention?

Infraclavicular nerve blocks, a form of regional anesthesia, are commonly used to manage pain by blocking pain signals from the affected extremity. Known side effects of infraclavicular blocks include transient adverse events such as numbness, paraesthesias, and superficial burns. Additionally, there may be an increased risk of incomplete nerve block, leading to inadequate pain relief. Other regional anesthesia techniques, like genicular nerve blocks for knee pain, can also cause temporary discomfort and, in rare cases, more severe complications such as infection or nerve damage. Overall, while effective, these treatments require careful administration to minimize potential side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management that are similar to infraclavicular nerve blocks. These include the use of local anesthetics such as lidocaine and bupivacaine for nerve blocks, which are effective in reducing pain by blocking pain signals from the affected area. For instance, lidocaine has been used in infrapatellar nerve blocks to alleviate knee pain, and bupivacaine has been utilized in genicular nerve blocks for knee osteoarthritis. These treatments are part of a broader category of regional anesthesia techniques aimed at providing targeted pain relief.

What other types of research exist?

Promising novel alternatives to infraclavicular nerve block for pain management include: 1) Continuous Adductor Canal Block, which has shown superior outcomes in promoting early ambulation and functional recovery after knee surgeries. 2) Local Infiltration Analgesia (LIA), which involves the direct injection of anesthetics into the surgical site and has been effective in joint replacement surgeries. 3) Ultrasound-guided Genicular Nerve Block, which is used for pain control after knee replacement surgeries. 4) Percutaneous Peripheral Nerve Stimulation, a minimally invasive technique for postoperative pain management. These alternatives offer targeted pain relief with potential benefits in recovery and reduced opioid consumption.

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Regional Anesthesia for Broken Arm

Phase 4

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fractures treated with open reduction percutaneous pinning requiring fixation

Isolated lateral condyle humerus fracture

Must not have

Pathologic fractures

Swelling requiring post-operative hospitalization for monitoring

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the puncture site from the nerve block or dressing application and any known side effects of ropivacaine like numbness or weakness in the area where it's given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to fix a broken bone with pins.

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

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

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I have a specific type of elbow fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had fractures due to my disease.

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I was hospitalized for swelling after surgery.

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I have a broken bone with related nerve or blood vessel damage.

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I am allergic to ropivacaine or oxycodone.

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I have a broken bone that is exposed through my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Wong-Baker FACES Pain Scale-Revised (FPSR)

Secondary study objectives

Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire

Other study objectives

Pain Medication Logs (Amount Taken)

Pain Medication Logs (Side Effects)

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Infraclavicular Regional BlockExperimental Treatment1 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 WoundPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Infraclavicular nerve blocks, a form of regional anesthesia, work by injecting local anesthetics near the brachial plexus to block pain signals from the affected extremity. This method prevents the transmission of pain signals to the brain, providing effective pain relief. Other common treatments include systemic analgesics like opioids, which bind to opioid receptors in the brain and spinal cord to reduce pain perception, and nonsteroidal anti-inflammatory drugs (NSAIDs), which inhibit enzymes involved in inflammation and pain. For pain patients, understanding these mechanisms is crucial as it helps in selecting the most appropriate and effective pain management strategy, potentially reducing the need for systemic medications and their associated side effects.

A randomized comparison between ultrasound-guided costoclavicular and infraclavicular block for upper extremity surgery A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery.Comparing vertical and coracoid approaches for infraclavicular block in orthopedic surgery of the forearm and hand.