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Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interscalene block (ISB) | Experimental | The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. |
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| superior trunk block (STB) | Experimental | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Anesthetic that will help treat pain and sensation after shoulder arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery. | Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers |
| Numerical Pain Rating System (NRS) Pain Scores | Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine. | Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System |
| Measure | Description | Time Frame |
|---|---|---|
| Block Duration | Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call | Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call. |
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Inclusion Criteria:
Exclusion Criteria:
Pre-existing neuropathy of the operative limb
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| Name | Affiliation | Role |
|---|---|---|
| David H Kim, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interscalene Block (ISB) | The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
| FG001 | Superior Trunk Block (STB) | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interscalene Block (ISB) | The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery. | Posted | Number | participants | Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers |
|
From Post Op Day 1 to Post Op Day 7
Incidence of paresthesia / neuropraxia ( POD1, POD ): persistent tingling, numbness in POD1, if patient reports persistent neuropraxia after POD2, will follow up on POD7. If persists, will notify attending anesthesiologist and continue to follow until postoperative neurologic symptoms (PONS) resolves.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interscalene Block (ISB) | The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kim | Department of Anesthesiology, Critical Care & Pain Management | 212-606-1206 | kimd@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2019 | Feb 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010146 | Pain |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ultrasound | Device | Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
|
| BG001 | Superior Trunk Block (STB) | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Length of Surgery | Median | Inter-Quartile Range | minutes |
|
| ASA Class | ASA Classification System is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA1 is a normal healthy patient. ASA2 is a patient with mild systemic disease and ASA3 is a patient with severe systemic disease. | Number | participants |
|
| Laterality | Number | participants |
|
| Baseline NRS | Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Superior Trunk Block (STB) | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks |
|
|
| Primary | Numerical Pain Rating System (NRS) Pain Scores | Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine. | Posted | Median | Inter-Quartile Range | units on a scale | Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System |
|
|
|
| Secondary | Block Duration | Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call | Posted | Median | Inter-Quartile Range | Hours | Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call. |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Superior Trunk Block (STB) | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks | 0 | 63 | 0 | 63 | 0 | 63 |
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| D000588 |
| Amines |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |