Effect of Interscalene Block on Obstructive Sleep Apnea in Shoulder Surgery Patients

Withdrawn before enrolling

Conditions studied: Obstructive Sleep Apnea

In brief

Obstructive Sleep Apnea (OSA) is when a person stops breathing repeatedly during sleep. Breathing stops because the airway collapses and prevents air from getting into the lungs.This airway closure results in a decrease in the amount of oxygen that is in the blood. Anesthetics given during surgery are known to increase the tendency for a patient's airway to close immediately after surgery in the recovery room and to reduce the amount of oxygen in a patient's blood immediately after surgery. These two factors combined could have a profound effect on a patient's well being after surgery. Recent advances in general anesthesia, pain medications, and surgical techniques have made outpatient surgery more common. Due to the increase in outpatient surgeries, pain management techniques that will work efficiently and for longer periods of time are necessary. One of these techniques is a nerve block, which coats the nerve with a numbing medication and blocks all pain from that area. Nerve blocks are routinely used along with general anesthesia for outpatient surgeries and help reduce or eliminate the need for IV or oral pain medicine after the surgery. Nerve blocks can provide good pain relief with early recovery and fewer side effects (nausea, vomiting, etc.) related to narcotic pain medicines. Unfortunately, there are no studies that look at the effect of anesthesia and nerve blocks on breathing patterns and oxygen saturation levels after discharge from outpatient surgery. We therefore propose to study the changes in lung function tests and blood oxygen levels after a nerve block and general anesthesia for outpatient shoulder surgery. We would like to conduct a home sleep study including measuring oxygen levels while subjects are sleeping, before, during and after surgery, and test lung function both before and after surgery to see if there are any differences. We will recruit 10 subjects with eligibility based on clinically indicated shoulder surgery and a nerve block. The study will be non-interventional during surgery. It is possible that future screening for out-patient shoulder surgery includes preoperative overnight oxygen saturation measurement to identify patients at high-risk of changes in oxygen levels. These patients may benefit from hospital admission after surgery for close observation. Thus, this study could have significant implications for patient safety and resource utilization.

Key facts

Study ID: NCT02034370
Run by: University of Michigan
People needed: 0
Starts: 2014-03-01
Expected to finish: 2015-08-01
Last updated by the study team: 2016-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Any adult 18 years of age or older
Six or more of the following risk factors (P-SAP score): age > 43, male gender, body mass index >30, diabetes, high blood pressure, snoring at night, neck circumference > 17 inches, reduced thyromental distance, and/or modified Mallampati class of 3 or 4
Scheduled for an outpatient elective shoulder surgery for which an interscalene nerve block is scheduled for postoperative pain control along with a general anesthetic per the surgeon

You may not qualify if…

Age <18 years old
Patients on home oxygen therapy, existing OSA that is treated with Continuous Positive Airway Pressure or Bilevel Positive Airway Pressure machine
Unable or unwilling to provide consent
Prisoners
Non-English speaking
Pregnant
Hearing impaired
Chronic pain present for 3 months or longer requiring >3 pills a day of opioid pain/pain modifying medications
Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin-norepinephrine reuptake inhibitor, tramadol, corticosteroids, or clonidine.
Preexisting nerve damage/peripheral neuropathy
Significant respiratory, kidney, liver or cardiovascular impairment
Coagulation/bleeding disorders
Uncontrolled diabetes
Drug or alcohol abuse
Uncontrolled anxiety, schizophrenia or bipolar disorder
Hearing impairment
American Society of Anesthesiologists class IV or V

Where it is running

Domino's Farm's Preoperative Clinic — Ann Arbor, Michigan, United States
University of Michigan Hospitals — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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