Sleep Disordered BreathingOSA-ISBNCT03718858
The Impact of Interscalene Block on Sleep Disordered Breathing
A study testing Interscalene Block and Superior Trunk Nerve Block in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Women's College Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea
- What is being tested?
- Interscalene Block and Superior Trunk Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Jul 2021to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Women's College Hospital
Toronto, ON Ontario, M5S 1B2
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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
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.
Read the 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.
- Being tested
- Interscalene Block, Superior Trunk Nerve Block
- Keywords
- sleep, Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene BlockProcedure or surgery
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 BlockProcedure or surgery
15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to Superior Trunk Nerve.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Superior Trunk Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Rate of diaphragmatic function (complete, partial, or none) will be assessed before and after surgery using M-Mode Ultrasound. Assessment will be performed during quiet breathing, sniffing, and deep breathing. After surgery diaphragmatic paresis will be indicated by a flat trace (absence of excursion) with quiet and deep breathing and/or with paradoxical motion. Measurement of amplitude of excursion will be made when partial paresis is observed. Using the sniff maneuver, complete hemi-diaphragmatic paresis (reduction of >75% from baseline) and partial paresis (reduction of 25-75%from baseline) will be recorded. Rate will be assessed in the basal state (i.e. before regional anesthesia) to establish a baseline, and again in the post-operative period.
Measured: 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
Change in pulmonary function tests [Forced vital capacity (FVC), forced expiratory volume in 1s (FEV1), Expiratory reserve volume (ERV) and peak expiratory flow (PEF) ], between before and after surgery will be measured by bedside spirometry
Measured: 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
Respiratory events in recovery room (Oxygen saturation < 90% (3 episodes), bradypnea < 8 breaths / min (3 episodes), apnea ≥ 10s (1 episode) will be recorded.
Measured: Within 24 hours of the time of surgery
Visual Analogue Scale (VAS) pain scores
Measurement of hourly and daily Visual Analogue Scale (VAS) pain scores. VAS: 10cm scale where 0=no pain, 10=worst pain.
Measured: 8 hours and 24 hours after surgery.
Analgesia requirements
Opioid and other pain killers consumption will be recorded intra and post-operatively
Measured: Day 1 of surgery.
Patient satisfaction with analgesia
A follow up call will be made on day 1 and day 30 to collect overall satisfaction with pain control. Overall satisfaction will be assessed on a 7-point Likert scale of 1-not at all satisfied with pain control, 2-mostly unsatisfied with pain control, 3-slightly unsatisfied with pain control, 4-no opinion, 5-slightly satisfied with pain control, 6-mostly satisfied with pain control, 7-completely satisfied with pain control
Measured: 8 hours and 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start23 Jul 2021
- Primary completion21 Jun 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is two-arm, prospective, parallel, double blind, multi center, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Dr. Mandeep Singh, Principal investigator, Women's College Hospital and Toronto Western Hospital, University Health NetworkDr. Richard Brull, Principal investigator, Women's College Hospital and Toronto Western Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718858
- Sponsor's protocol ID
- 2018-0037-B
- Acronym
- OSA-ISB
- Status last verified
- Aug 2024
- First submitted
- 10 Sep 2018
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03718858
- Acronym / sponsor ID
- OSA-ISB / 2018-0037-B
- Keywords
- sleep, Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is two-arm, prospective, parallel, double blind, multi center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Experimental | Procedure: Interscalene BlockUnder 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 block | Active comparator | Procedure: Superior Trunk Nerve BlockUnder 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene Block15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots. | Procedure or surgery | Interscalene block |
| Superior Trunk Nerve Block15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to Superior Trunk Nerve. | Procedure or surgery | Superior Trunk Nerve block |
Primary outcome
Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1).
Time frame: Time of measurements will be at baseline (pre operatively) and within 24 hours post-operatively (night of surgery)
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.
6 secondary outcomes
Change in amplitude of diaphragmatic excursion with breathing maneuvers, between before and after surgery (measured by ultrasound)
Time frame: 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 frame: 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
Time frame: Within 24 hours of the time of surgery
Visual Analogue Scale (VAS) pain scores
Time frame: 8 hours and 24 hours after surgery.
Analgesia requirements
Time frame: Day 1 of surgery.
Patient satisfaction with analgesia
Time frame: 8 hours and 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mandeep Singh principal investigator
Women's College Hospital and Toronto Western Hospital, University Health Network
Dr. Richard Brull principal investigator
Women's College Hospital and Toronto Western Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene Block and Superior Trunk Nerve Block in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Women's College Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen desaturation index (ODI) from baseline to the night of surgery (post- operation) (N1). (time frame: Time of measurements will be at baseline (pre operatively) and within 24 hours post-operatively (night of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.