The Impact of Interscalene Block on Sleep Disordered Breathing
Key facts
- Who runs it
- Women's College Hospital
- Where
- Canada2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 76 people enrolled
- Started
- 23 Jul 2021
- Ended
- 4 Jul 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Interscalene Block
- Superior Trunk Nerve Block
- Record updated
- 14 August 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous diaphragmatic paralysis
- Past history of head, neck or thoracic surgery (e.g., OSA corrective surgery)
- Local anesthetic allergy
- Pregnancy or lactation
- Phrenic nerve stimulators
- Inability to communicate with health care providers or the research personnel, inability to perform breathing maneuvers such as spirometry, or inability to follow instructions
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Interscalene blockTreatment being tested
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.
- Superior Trunk Nerve blockExisting treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 14 August 2024