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

NCT02034370 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2016-11-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Satya Krishna Ramachandran, MD · University of Michigan Anesthesiology Department

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034370 on ClinicalTrials.gov