Effect of Interscalene Block on Obstructive Sleep Apnea in Shoulder Surgery Patients
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|ClinicalTrials.gov Identifier: NCT02034370|
Recruitment Status : Withdrawn (Inclusion criteria not met at preoperative clinic visit screening. No eligible participants.)
First Posted : January 13, 2014
Last Update Posted : November 30, 2016
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.
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Device: Lung-function spirometry test Device: Overnight sleep test|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Target Follow-Up Duration:||1 Week|
|Official Title:||Influence of Inter-scalene Blockade on Postoperative Episodic Desaturation in Patients at High Risk of Obstructive Sleep Apnea (OSA)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
All ten patients included in this cohort. Shoulder surgery patients that are getting a nerve block and are at high risk for OSA. They will receive a Lung-function spirometry test and an overnight sleep test.
Device: Lung-function spirometry test
5 minute lung function test performed once preoperatively and once postoperatively
Device: Overnight sleep test
Somte sleep monitor to be worn two nights before and the night of surgery.
- Incidence of postoperative sleep disordered breathing [ Time Frame: The night after surgery ]The incidence of postoperative sleep disordered breathing (apnea-hypopnea index) defined as ≥5 episodes per hour of >50% reduction of expiratory air flow associated with a ≥4% reduction in oxygen saturation (referred to as ODI4 or oxygen desaturation index > or = to 4 points drop in SpO2) that lasts for at least 10 seconds each as measured by the pulse oximeter.
- Changes in lung function [ Time Frame: Once in Pre-op the day of surgery, and once in the Post Anesthesia Care Unit the day of surgery once the patient is sufficiently recovered from their procedure but before going home (all within 24 hours) ]As measured by spirometry test administered preoperatively and postoperatively
- Lowest oxygen saturation levels during sleep [ Time Frame: two nights before and night of surgery ]
- Mean oxygen saturation levels during sleep [ Time Frame: Two nights before and the night of surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034370
|United States, Michigan|
|Domino's Farm's Preoperative Clinic|
|Ann Arbor, Michigan, United States, 48109|
|University of Michigan Hospitals|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Satya Krishna Ramachandran, MD||University of Michigan Anesthesiology Department|