← Back to Search

Interscalene Block for Sleep Apnea (OSA-ISB Trial)

Q: Who is eligible to be a part of this medical research?

<p>Up to 76 patients with obstructive <a href="https://www.withpower.com/clinical-trials/sleep-apnea">sleep apnea</a>, aged 18-80 years old, who are slated for elective ambulatory shoulder procedures such as replacement and repairs may join this trial. Eligible participants must satisfy the age range requirement of over 18 and below 80 years.</p>

N/A

Recruiting

Led By Dr. Richard Brull

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)

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

OSA-ISB Trial Summary

This trial is testing whether a numbing injection near the shoulder can improve sleep problems caused by upper airway collapse.

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.Check my eligibility

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.See study design

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.

OSA-ISB Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My health is classified between ASA I and IV.

Select...

I am between 18 and 80 years old.

Select...

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

OSA-ISB Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

OSA-ISB 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

~150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor

102 Previous Clinical Trials

39,018 Total Patients Enrolled

University Health Network, TorontoOTHER

1,482 Previous Clinical Trials

486,340 Total Patients Enrolled

5 Trials studying Sleep Apnea

379 Patients Enrolled for Sleep Apnea

Dr. Richard BrullPrincipal InvestigatorWomen's College Hospital and Toronto Western Hospital, University Health Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons of octogenarian age or younger eligible for this research endeavor?

"Candidates for this trial must be 18 years or above, but not exceed 80 years in age."

Answered by AI

Are there available vacancies in this clinical experiment?

"Affirmative. As per the information made available on clinicaltrials.gov, this medical trial is in need of volunteers to participate. First posted on July 23rd 2021 and last edited November 3rd 2021, 76 participants are expected from two sites."

Answered by AI

How many people are enrolled in this medical experiment?

"Affirmative, the data hosted on clinicaltrials.gov demonstrates that this experiment is actively seeking participants. The trial was initially posted on July 23rd 2021, and has been adjusted as recently as November 3rd 2021. An estimated 76 people need to be recruited across two sites for participation in the study."

Answered by AI

Who is eligible to be a part of this medical research?

"Up to 76 patients with obstructive sleep apnea, aged 18-80 years old, who are slated for elective ambulatory shoulder procedures such as replacement and repairs may join this trial. Eligible participants must satisfy the age range requirement of over 18 and below 80 years."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Interscalene Block on Sleep Disordered Breathing

2021. "The Impact of Interscalene Block on Sleep Disordered Breathing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03718858.

All > Sleep Disorder > Sleep