The Impact of Interscalene Block on Sleep Disordered Breathing

NCT ID: NCT03718858

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2024-07-04

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.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Interscalene block

Under sterile precautions, a high frequency linear array transducer \[6-13 Megahertz (MHz), Sonosite M-Turbo\] probe will be placed in the transverse plane over the interscalene groove to visualize the carotid artery and the C5 and C6 nerve roots of the brachial plexus between the anterior and middle scalene muscles. A 5 cm 22 G insulated needle will then be inserted in line with the US probe in a lateral-to-medial approach until the needle tip is adjacent to the C5 and C6 roots. After negative aspiration for blood, 15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots.

Group Type: EXPERIMENTAL

Interscalene Block

Intervention Type: PROCEDURE

15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots.

Superior Trunk Nerve block

Under sterile precautions, a high frequency linear array transducer \[6-13 Megahertz (MHz), Sonosite M-Turbo\] probe will be placed in the transverse plane over the interscalene groove to visualize the carotid artery and the C5 and C6 nerve roots of the brachial plexus between the anterior and middle scalene muscles. The superior trunk will be identified by tracing the C5 and C6 nerve roots caudally towards the supraclavicular fossa on the anterior lateral portion of the neck. A 5 cm 22 G insulated needle will then be inserted in line with the US probe in a lateral-to-medial approach until the needle tip is properly positioned. After negative aspiration for blood, 15 mL ropivacaine 0.5% will be injected in 5 mL aliquots.

Group Type: ACTIVE_COMPARATOR

Superior Trunk Nerve Block

Intervention Type: PROCEDURE

15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to Superior Trunk Nerve.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Mandeep Singh

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital and Toronto Western Hospital, University Health Network

Dr. Richard Brull

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital and Toronto Western Hospital, University Health Network

Locations

Women's College Hospital

Toronto, ON Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2018-0037-B

Identifier Type: -

Identifier Source: org_study_id