The Impact of Interscalene Block on Sleep Disordered Breathing

NCT03718858 | Completed DMC

• 1 other identifier: 2018-0037-B
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Keywords

sleep; Apnea

Outcome Measures

Primary Outcomes (1)

• Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).

  All patients will undergo a portable overnight oximetry study at home to establish the baseline oxygen saturation measured hourly. Oxygen Desaturation Index (ODI), which is defined as a 4% drop in oxygenation from the baseline, and calculated as events occurring per hour during the recording time; the minimum and mean oxygen saturation ; and the cumulative total of recoded time below an oxygen saturation of 90%, CT90). Patients with preoperative ODI with more than a score of 10 will be considered at risk of SDB. A change from baseline will be examined and compared between the two groups.

  Time of measurements will be at baseline (pre operatively) and within 24 hours post-operatively (night of surgery)

Secondary Outcomes (6)

• Change in amplitude of diaphragmatic excursion with breathing maneuvers, between before and after surgery (measured by ultrasound)

  Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 10-15 minutes.

• Change in pulmonary function before and after surgery, as measured by bedside spirometry

  Time of measurements will be within 1 hour before surgery, and within 1 hour after surgery. It will take around 5-10 minutes.

• Post operative respiratory events

  Within 24 hours of the time of surgery

• Visual Analogue Scale (VAS) pain scores

  8 hours and 24 hours after surgery.

• Analgesia requirements

  Day 1 of surgery.

Study Arms (2)

Interscalene block

EXPERIMENTAL

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.

Procedure: Interscalene Block

Superior Trunk Nerve block

ACTIVE COMPARATOR

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.

Procedure: Superior Trunk Nerve Block

Interventions

Interscalene Block 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.

Interscalene block

Superior Trunk Nerve Block PROCEDURE

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

Superior Trunk Nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Women's College Hospital

Toronto, ON Ontario, M5S 1B2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Mandeep Singh

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

  PRINCIPAL INVESTIGATOR

• Dr. Richard Brull

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: On the day of surgery, patients will be randomly assigned (1:1) to one of two groups according to a computer-generated list. The patients, the clinical care team (anesthesiologist providing intraoperative care, nurses, and surgeons), data collectors, outcome adjudicators, and the study statisticians will all remain blinded to randomization and group allocation. The anesthesiologist who will perform the intervention will be aware of group allocation, but the anesthesiologist providing intraoperative care will remain blinded. Situations such as patient refusal at any time of the study, any adverse event or complication necessitating withholding the intervention would result in voluntary un-blinding of study investigators.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is two-arm, prospective, parallel, double blind, multi center, randomized controlled trial

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: October 25, 2018
• Study Start: July 23, 2021
• Primary Completion: June 21, 2024
• Study Completion: July 4, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CA (2)