What is the mechanism of action of this treatment?

Common treatments for Sleep Apnea include continuous positive airway pressure (CPAP) therapy, which maintains airway patency by providing a constant stream of air through a mask, and pharmacotherapy that targets upper airway motor circuitry to enhance muscle tone and reflexes. Neurotoxinological interventions aim to improve neuromuscular function of the upper airway. These treatments are crucial as they address the underlying issues of airway collapse and muscle tone loss, which are central to Sleep Apnea. Similar to the Interscalene Block, which blocks nerve signals to prevent pain, these treatments work by modulating nerve and muscle function to maintain an open airway during sleep, thereby improving breathing and reducing apneic events.

What side effects are associated with this type of intervention?

Common treatments for sleep apnea include CPAP therapy, mandibular advancement devices, and various pharmacological agents. CPAP therapy can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Mandibular devices may lead to jaw discomfort and dental issues. Pharmacological treatments, including hypnotics and sedatives, can exacerbate upper airway instability and lead to increased severity of sleep apnea. Interscalene Block, a form of regional anesthesia, may cause side effects such as nerve damage, infection, and respiratory complications, particularly in patients with pre-existing sleep-disordered breathing.

What prior FDA approvals exist?

The FDA has approved several treatments for Sleep Apnea, including continuous positive airway pressure (CPAP) devices, oral appliances, and surgical interventions. One notable FDA-approved treatment that involves nerve stimulation is the Inspire therapy, which uses an implantable device to stimulate the hypoglossal nerve, thereby preventing airway collapse. This is somewhat similar to the concept of using regional anesthesia to block nerve signals, as studied in the Interscalene Block trial. However, specific FDA approvals for treatments directly analogous to regional anesthesia for Sleep Apnea are not well-documented.

What other types of research exist?

A promising alternative to interscalene block for sleep apnea patients is the combined suprascapular-axillary nerve block (SSB). This method has been shown to be noninferior to interscalene block in treating pain after arthroscopic shoulder surgery, with secondary benefits including reduced opioid consumption and less discomfort associated with muscle weakness.

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Interscalene Block for Sleep Apnea (OSA-ISB Trial)

N/A

Waitlist Available

Led By Dr. Mandeep Singh

Research Sponsored by Women's College Hospital

Eligibility Criteria Checklist

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

Must have

American Society of Anesthesiology (ASA) physical status I-IV

Adult patients ( >18 to 80 years)

Must not have

Past history of head, neck or thoracic surgery (e.g., OSA corrective surgery)

Previous diaphragmatic paralysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. it will take around 5-10 minutes.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a specific type of anesthesia that numbs the shoulder affects breathing problems in patients with sleep disordered breathing during shoulder surgery. This patient group is chosen because they have a high risk of breathing issues during surgery. The anesthesia works by blocking nerve signals to stop pain but might also temporarily affect breathing. This technique is common for shoulder surgery but can be problematic for patients with compromised lung function.

Who is the study for?

This trial is for adults aged 18 to 80 who are having elective shoulder surgery (like shoulder replacement or rotator cuff repair) and can perform breathing tests like spirometry. It's not for those with a history of certain surgeries, pregnant or breastfeeding women, people with phrenic nerve stimulators, previous diaphragmatic paralysis, local anesthetic allergies, or communication difficulties.

What is being tested?

The study is testing whether interscalene block or superior trunk nerve block affects sleep disordered breathing in patients after outpatient shoulder surgery. Participants will be randomly assigned to receive one of these two types of nerve blocks during their procedure.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, weakness in the arm due to nerve blockage, shortness of breath if the diaphragm is affected, and changes in blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

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

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My health is classified between ASA I and IV.

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I am between 18 and 80 years old.

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I am scheduled for shoulder surgery like replacement or rotator cuff repair under general anesthesia.

Exclusion Criteria

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

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I have had surgery on my head, neck, or chest area.

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I have had paralysis of the diaphragm before.

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I can communicate with my healthcare team and follow instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. it will take around 10-15 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. it will take around 10-15 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. it will take around 10-15 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

Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).

Secondary study objectives

Analgesia requirements

Change in amplitude of diaphragmatic excursion with breathing maneuvers, between before and after surgery (measured by ultrasound)

Change in pulmonary function before and after surgery, as measured by bedside spirometry

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interscalene blockExperimental Treatment1 Intervention

Under sterile precautions, a high frequency linear array transducer \[6-13 Megahertz (MHz), Sonosite M-Turbo\] probe will be placed in the transverse plane over the interscalene groove to visualize the carotid artery and the C5 and C6 nerve roots of the brachial plexus between the anterior and middle scalene muscles. A 5 cm 22 G insulated needle will then be inserted in line with the US probe in a lateral-to-medial approach until the needle tip is adjacent to the C5 and C6 roots. After negative aspiration for blood, 15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots.

Group II: Superior Trunk Nerve blockActive Control1 Intervention

Under sterile precautions, a high frequency linear array transducer \[6-13 Megahertz (MHz), Sonosite M-Turbo\] probe will be placed in the transverse plane over the interscalene groove to visualize the carotid artery and the C5 and C6 nerve roots of the brachial plexus between the anterior and middle scalene muscles. The superior trunk will be identified by tracing the C5 and C6 nerve roots caudally towards the supraclavicular fossa on the anterior lateral portion of the neck. A 5 cm 22 G insulated needle will then be inserted in line with the US probe in a lateral-to-medial approach until the needle tip is properly positioned. After negative aspiration for blood, 15 mL ropivacaine 0.5% will be injected in 5 mL aliquots.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interscalene Block

2016

Completed Phase 3

~230

0 / 6Eligibility 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

Common treatments for Sleep Apnea include continuous positive airway pressure (CPAP) therapy, which maintains airway patency by providing a constant stream of air through a mask, and pharmacotherapy that targets upper airway motor circuitry to enhance muscle tone and reflexes. Neurotoxinological interventions aim to improve neuromuscular function of the upper airway. These treatments are crucial as they address the underlying issues of airway collapse and muscle tone loss, which are central to Sleep Apnea. Similar to the Interscalene Block, which blocks nerve signals to prevent pain, these treatments work by modulating nerve and muscle function to maintain an open airway during sleep, thereby improving breathing and reducing apneic events.

Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.A resource of potential drug targets and strategic decision-making for obstructive sleep apnoea pharmacotherapy.Sleep-disordered breathing and resistant hypertension.