Clinical trial NCT03718858: The Impact of Interscalene Block on Sleep Disordered Breathing
Official title: Evaluating the Impact of Interscalene Brachial Plexus Block on Sleep-disordered Breathing in Patients Undergoing Ambulatory Shoulder Surgery. A Two-arm, Prospective, Parallel, Double Blind Randomized -Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Keywords: sleep
Apnea
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2018-10-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is two-arm, prospective, parallel, double blind, multi center, randomized controlled trial
Primary purpose: OTHER

Brief summary: This is a randomized controlled trial evaluating the impact of interscalene block on worsening of upper airway collapse in sleep disordered breathing for patients undergoing ambulatory shoulder surgery.

Detailed description: Sleep disordered Breathing (SDB), closely associated with obesity, is a highly prevalent, serious, and often unrecognized breathing disorder resulting from repeated upper airway collapse, decreased oxygen levels, and a very high risk of life threatening complications at the time of surgery. Current guidelines recommend using regional as opposed to general anesthesia in SDB patients to minimize risks and the use of strong narcotic medications. It is unclear whether interscalene block in use for analgesia (pain relief) may actually worsen the severity of SDB by invariably freezing the phrenic nerve, thereby temporarily paralyzing the diaphragm.

This novel clinical trial will examine whether or not ISB increases the rate of upper airway obstruction or collapse during sleep and other dangerous postoperative complications seen in patients with SDB following shoulder surgeries.

The Primary Objective of the study is to evaluate the impact of ISB on the oxygen desaturation index (sleep apnea severity) in untreated SDB patients undergoing ambulatory shoulder surgery compared to patients who do not receive ISB.

Secondary Objectives are: 1) To evaluate the impact of hemidiaphragmatic paresis on impairment in pulmonary function; 2) To evaluate the impact of impairment in pulmonary function on the oxygen desaturation index (ODI); 3) To assess the incidence of important perioperative clinical outcomes such as hypoxemia, recurrent respiratory events, delayed discharge, and resource utilization in SDB patients undergoing ambulatory shoulder surgery compared to patients who do not receive ISB; and 4) To assess important analgesia related outcomes such as: time to onset of pain, intraoperative and postoperative opioid consumption, hourly and daily VAS pain scores, opioid related side effects, patient satisfaction with analgesia, and presence/absence of nerve block complications.

Eligibility criteria: Inclusion Criteria:

* Adult patients ( \>18 to 80 years);
* American Society of Anesthesiology (ASA) physical status I-IV;
* Undergoing elective ambulatory shoulder surgery such as shoulder replacement, acromioplasty, rotator cuff repair, or Bankart procedure under general anesthesia.

Exclusion Criteria:

* Past history of head, neck or thoracic surgery (e.g., OSA corrective surgery);
* Pregnancy or lactation;
* Phrenic nerve stimulators;
* Local anesthetic allergy;
* Previous diaphragmatic paralysis;
* Inability to communicate with health care providers or the research personnel, inability to perform breathing maneuvers such as spirometry, or inability to follow instructions.

Primary outcomes:
measure: Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).
timeFrame: Time of measurements will be at baseline (pre operatively) and within 24 hours post-operatively (night of surgery)
Secondary outcomes:
measure: Change in amplitude of diaphragmatic excursion with breathing maneuvers, between before and after surgery (measured by ultrasound)
timeFrame: Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 10-15 minutes.
measure: Change in pulmonary function before and after surgery, as measured by bedside spirometry
timeFrame: Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 5-10 minutes.
measure: Post operative respiratory events
timeFrame: Within 24 hours of the time of surgery
measure: Visual Analogue Scale (VAS) pain scores
timeFrame: 8 hours and 24 hours after surgery.
measure: Analgesia requirements
timeFrame: Day 1 of surgery.
measure: Patient satisfaction with analgesia
timeFrame: 8 hours and 24 hours after surgery.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: ON Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital and Toronto Western Hospital, University Health Network
name: Dr. Mandeep Singh
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital and Toronto Western Hospital, University Health Network
name: Dr. Richard Brull
role: PRINCIPAL_INVESTIGATOR
References: