NCT03718858

The Impact of Interscalene Block on Sleep Disordered Breathing

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disordered Breathing
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	Interscalene Block	15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots.
PROCEDURE	Superior Trunk Nerve Block	15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to Superior Trunk Nerve.

Timeline

• Start date: 2021-07-23
• Primary completion: 2024-06-21
• Completion: 2024-07-04
• First posted: 2018-10-25
• Last updated: 2024-08-14

Locations

2 sites across 1 country: Canada