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

NCT02034370 | Withdrawn DMC

• 1 other identifier: 36398
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Obstructive Sleep Apnea

Keywords

Interscalene nerve block; Shoulder surgery; Obstructive Sleep Apnea; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative sleep disordered breathing

  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.

  The night after surgery

Secondary Outcomes (1)

• Changes in lung function

  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)

Other Outcomes (2)

• Lowest oxygen saturation levels during sleep

  two nights before and night of surgery

• Mean oxygen saturation levels during sleep

  Two nights before and the night of surgery

Study Arms (1)

Included patients

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; Device: Overnight sleep test

Interventions

Lung-function spirometry test DEVICE

5 minute lung function test performed once preoperatively and once postoperatively

Included patients

Overnight sleep test DEVICE

Somte sleep monitor to be worn two nights before and the night of surgery.

Included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population consists of patients who are receiving an interscalene nerve block as an anesthetic for their scheduled shoulder surgery, and are at risk for OSA.

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

Domino's Farm's Preoperative Clinic

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

  PMID: 8464434 BACKGROUND

• Fu ES, Downs JB, Schweiger JW, Miguel RV, Smith RA. Supplemental oxygen impairs detection of hypoventilation by pulse oximetry. Chest. 2004 Nov;126(5):1552-8. doi: 10.1378/chest.126.5.1552.

  PMID: 15539726 BACKGROUND

• Tobias JD, Del Campo L, Kenter K, Groeper K, Gray B, Edwards J. Changes in transcutaneous carbon dioxide, oxygen saturation, and respiratory rate after interscalene block. South Med J. 2004 Jan;97(1):21-4. doi: 10.1097/01.SMJ.0000054425.08030.B0.

  PMID: 14746417 BACKGROUND

• Ramachandran SK, Kheterpal S, Consens F, Shanks A, Doherty TM, Morris M, Tremper KK. Derivation and validation of a simple perioperative sleep apnea prediction score. Anesth Analg. 2010 Apr 1;110(4):1007-15. doi: 10.1213/ANE.0b013e3181d489b0.

  PMID: 20357144 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Satya Krishna Ramachandran, MD

  University of Michigan Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 13, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

US (2)