What side effects are associated with this type of intervention?

Nerve blocks, which involve the injection of pain medication next to the nerve, are generally considered safe and effective for reducing post-operative pain. However, potential side effects include transient pain at the injection site, temporary numbness, and in rare cases, systemic toxicity if local anesthetics are used. Other injection-based treatments, such as botulinum toxin injections, may cause transient weakness and prolonged muscle weakness in some cases. Prolotherapy, which involves injecting irritants to elicit an inflammatory response, can lead to temporary increases in pain and stiffness, and occasionally post-injection headaches. Overall, while these treatments are effective, they carry risks of localized and sometimes systemic side effects.

What prior FDA approvals exist?

The FDA has approved various interventional therapies for pain management, including nerve blocks and epidural steroid injections. Nerve blocks involve the injection of pain medication, such as local anesthetics or steroids, next to the nerve to decrease pain, commonly used post-operatively. Epidural steroid injections are another approved method, particularly for radicular pain, providing short-term pain relief. Additionally, other interventional procedures like radiofrequency ablation and intrathecal drug delivery systems have been utilized for chronic pain management. These treatments aim to target pain generators or work at a spinal level to alleviate pain.

What other types of research exist?

Promising novel alternatives to nerve blocks for pain management include: 1) Ultrasound-guided regional anesthesia techniques, which improve the precision and effectiveness of nerve blocks. 2) Long-acting local anesthetics and adjuvants that extend the duration of pain relief. 3) Continuous peripheral nerve blocks, such as continuous femoral nerve blocks, which provide prolonged analgesia. 4) Pharmacological options like gabapentin and pregabalin for neuropathic pain. 5) Non-opioid medications and adjuvant analgesics, including acetyl-L-carnitine and capsaicin patches. 6) Intradiscal and epidural steroid injections for specific types of pain, such as sciatica and chronic low back pain.

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Nerve Block Timing for Shoulder Pain

N/A

Waitlist Available

Led By Marc Mecoli, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

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

Must have

The subject is American Society of Anesthesiologists (ASA) patient classification I-II

The subject is age 10 years to 21 years (inclusive)

Must not have

Additional surgical procedures are being performed concurrently

The subject is ASA classification > II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a procedure where pain medication is injected near neck nerves to manage pain after shoulder surgery. It targets healthy adolescents having shoulder reconstruction. The treatment works by numbing the nerves to block pain signals, helping reduce the need for other painkillers and speeding up recovery. This method has been found to be the most effective way to control pain after shoulder surgery.

Who is the study for?

This trial is for individuals aged 10-21 years with shoulder injuries requiring surgery, who are in good health (ASA I-II). They must consent to a nerve block and not have other surgeries at the same time. Excluded are those with severe health issues, pre-op sedation, allergies to local anesthetics, or conditions making them unsuitable for the study.

What is being tested?

The study compares different timings of administering a nerve block—either before or after shoulder surgery—to see which method better reduces post-operative pain. Participants will receive either a single shot or continuous catheter-delivered nerve blockade.

What are the potential side effects?

Potential side effects from the nerve blocks may include discomfort at injection site, weakness or numbness in the arm temporarily due to anesthesia effect on nerves, and less commonly allergic reactions to the medication used.

Eligibility Criteria

Inclusion Criteria

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

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I am in good or mild systemic disease condition according to ASA.

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I am between 10 and 21 years old.

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I have agreed to a specific type of anesthesia for my procedure, and a qualified clinician not involved in the study has obtained my consent.

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I am scheduled for a one-sided shoulder surgery under general anesthesia without any other surgeries.

Exclusion Criteria

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

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I am having more than one surgery at the same time.

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My health status is considered to be more than mildly compromised.

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I will be given sedation before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain Efficacy of Nerve Blockades

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Preemptive Interscalene Block - Single ShotActive Control1 Intervention

Group II: Postoperative Interscalene Block - Single ShotActive Control1 Intervention

Group III: Preemptive Interscalene Block - CatheterActive Control1 Intervention

Group IV: Postoperative Interscalene Block - CatheterActive Control1 Intervention

0 / 7Eligibility 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

Nerve blocks work by injecting anesthetics or steroids near nerves to interrupt pain signals, providing targeted relief and reducing the need for systemic medications. This is particularly effective for post-operative pain management. Other common treatments include opioids, which reduce pain perception by binding to receptors in the brain and spinal cord, and NSAIDs, which inhibit enzymes involved in inflammation and pain. Understanding these mechanisms is crucial for selecting the most appropriate and effective pain management strategy, minimizing side effects, and improving patient outcomes.