Nerve of Arnold Block for Postoperative Pain
(NOA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a potential new method to manage pain for children undergoing ear tube surgery. Current treatments involve opioids, which can cause side effects like nausea and breathing problems. The study examines the use of a Nerve of Arnold block, a numbing injection near the ear, which might control pain without those side effects. Children aged 6 months to 6 years scheduled for ear tube surgery, without allergies to the study drugs, might be suitable candidates. If successful, this could provide a safer pain relief option for children after surgery. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment benefits more patients, offering a safer pain relief option for children.
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, if you have recently used analgesics (pain relievers) within 24 hours, you may not be eligible to participate.
What is the safety track record for the Nerve of Arnold Block?
Research has shown that nerve blocks, such as the Nerve of Arnold block, hold promise for managing post-surgical pain. They can reduce the need for opioids, which often cause side effects like nausea and drowsiness. Studies have found that these nerve blocks effectively lower pain and opioid use after surgeries, leading to better patient outcomes.
While specific data on the Nerve of Arnold block is lacking, its use as a type of regional anesthesia suggests it could offer targeted pain relief with fewer side effects than standard opioid treatments. This makes it a potentially safer option for children undergoing ear surgeries.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the Nerve of Arnold Block for postoperative pain because it offers a novel approach by targeting the nerves directly with a combination of bupivacaine, epinephrine, and dexmedetomidine. Unlike traditional treatments like intramuscular fentanyl and ketorolac, which primarily provide systemic pain relief, this nerve block aims to deliver localized, targeted pain control, potentially reducing the need for systemic opioids. This could mean fewer side effects and a quicker recovery for patients, making it an exciting development in pain management.
What evidence suggests that the Nerve of Arnold block is effective for postoperative pain in children undergoing BMT placement?
Research has shown that nerve blocks, such as the Nerve of Arnold block, can manage post-surgical pain and reduce opioid use, which often leads to side effects. In this trial, participants in the nerve block group will receive a bilateral Nerve of Arnold block with bupivacaine and dexmedetomidine. These nerve blocks are particularly promising for ear surgeries, providing targeted pain relief. The technique involves injecting a local anesthetic near specific nerves to numb the area, potentially offering longer-lasting pain relief with fewer side effects. Although high-quality evidence comparing this method to standard pain management in children is limited, it offers a safe and effective way to control pain without relying on opioids. Overall, the Nerve of Arnold block could serve as a valuable alternative to traditional opioid-based pain relief methods.12367
Are You a Good Fit for This Trial?
This trial is for children aged 6 months to 6 years undergoing ear surgery (BMT placement). It's not specified who can't join, but typically those with allergies or conditions that could interfere with the study might be excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard care with intramuscular fentanyl and ketorolac or bilateral Nerve of Arnold block with bupivacaine
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain assessment and adverse event monitoring
Data Analysis and Manuscript Preparation
Data analysis and preparation of the study manuscript
What Are the Treatments Tested in This Trial?
Interventions
- Nerve of Arnold Block
Trial Overview
The trial compares a standard pain relief method using fentanyl and ketorolac injections against a regional anesthesia technique called Nerve of Arnold block. The goal is to see if the nerve block controls pain just as well without opioid side effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive bilateral Nerve of Arnold block with bupivacaine 0.25% with epinephrine 1:200,000 (0.2 mL per side) plus dexmedetomidine 5 mcg per side (maximum total bupivacaine dose 2.5 mg/kg) after induction of anesthesia. sham intramuscular injection with normal saline is performed to maintain blinding.
Patients receive intramuscular fentanyl 2 mcg/kg (maximum 100 mcg) plus intramuscular ketorolac 0.5 mg/kg (maximum 30 mg) after induction of anesthesia. Sham bilateral Nerve of Arnold block with normal saline 0.2 mL per side is performed to maintain blinding.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Alabama
Lead Sponsor
Citations
Comparing Intramuscular Fentanyl and Ketorolac With ...
Study Objective: This study aims to determine whether the Nerve of Arnold block is non-inferior to the standard combination of IM fentanyl and ...
2.
ctv.veeva.com
ctv.veeva.com/study/comparing-intramuscular-fentanyl-and-ketorolac-with-nerve-of-arnold-noa-block-for-bilateral-myringComparing Intramuscular Fentanyl and Ketorolac With Nerve ...
Study Objective: This study aims to determine whether the Nerve of Arnold block is non-inferior to the standard combination of IM fentanyl and ...
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.
Comparative Efficacy of Nerve Blocks for Post-Operative ...
Methods: A systematic review was conducted to evaluate the effectiveness of different nerve block techniques on post-operative pain control ...
Comparative Study of Superficial Cervical Plexus
We would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the ...
Association of peripheral nerve blocks with increased ...
Peripheral nerve blocks are effective in reducing immediate postoperative pain and opioid use in orthopaedic surgeries, and potentially minimise ...
Association of peripheral nerve blocks with increased ...
Results: Among 22 956 patients, peripheral nerve block administration was associated with lower maximum pain scores and lower probability of ...
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