STB: Interscalene Block Versus Superior Trunk Block

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT03272139
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.3
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Joint Disease; Pain; Pain, Acute; Pain, Chronic	Drug: Bupivacaine; Device: Ultrasound	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
• Actual Study Start Date: Sep 28, 2017
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Jul 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Bupivacaine; Anesthetic that will help treat pain and sensation after shoulder arthroscopy; Device: Ultrasound; Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Experimental: 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.	Drug: Bupivacaine; Anesthetic that will help treat pain and sensation after shoulder arthroscopy; Device: Ultrasound; Ultrasound will help guide the anesthesiologist in performing the different nerve blocks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) [Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers]

   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.

2. Numerical Pain Rating System (NRS) Pain Scores [Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System]

   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.

Secondary Outcome Measures

1. Block Duration [Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.]

   Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder

• Age 18 to 80 years

• Planned use of general anesthesia with LMA and interscalene or superior trunk block

• Ability to follow study protocol

• English speaking

• ASA I - III

Exclusion Criteria:

Pre-existing neuropathy of the operative limb

• Younger than 18 years old and older than 80

• Patients with pulmonary severe respiratory disease

• Allergy to one of the study medications

• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

• Chronic opioid use (taking opioids for longer than 3 months)

• Contraindication to general anesthesia, interscalene or superior trunk block

• Herniated Cervical Disk, Cervical Myelopathy

• BMI >35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: David H Kim, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 3, 2019

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03272139
• Other Study ID Numbers: 2017-0979
• First Posted: Sep 5, 2017
• Last Update Posted: May 11, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Joint Diseases; Acute Pain; Chronic Pain; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Interscalene Block (ISB)	Superior Trunk Block (STB)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	63	63
COMPLETED	63	63
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Interscalene Block (ISB)	Superior Trunk Block (STB)	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	63	63	126
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	50.0	51.5	51
Sex: Female, Male (Count of Participants)
Female	19 30.2%	14 22.2%	33 26.2%
Male	44 69.8%	49 77.8%	93 73.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 6.3%	4 6.3%	8 6.3%
Not Hispanic or Latino	58 92.1%	58 92.1%	116 92.1%
Unknown or Not Reported	1 1.6%	1 1.6%	2 1.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.2%	0 0%	2 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	1 1.6%	1 0.8%
Black or African American	4 6.3%	4 6.3%	8 6.3%
White	52 82.5%	54 85.7%	106 84.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 7.9%	4 6.3%	9 7.1%
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	26.8	27.2	26.8
Length of Surgery (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	46.0	49.0	48
ASA Class (participants) [Number]
ASA 1	18 28.6%	10 15.9%	28 22.2%
ASA 2	44 69.8%	52 82.5%	96 76.2%
ASA 3	1 1.6%	1 1.6%	2 1.6%
Laterality (participants) [Number]
LEFT Shoulder Arthroscopy	28 44.4%	23 36.5%	51 40.5%
Right Shoulder Arthroscopy	35 55.6%	40 63.5%	75 59.5%
Baseline NRS (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	2.0	2.0	2.0

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
Description	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.
Time Frame	Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Block (ISB)	Superior Trunk Block (STB)
Arm/Group Description	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	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
Measure Participants	63	62
HDP	45 71.4%	3 4.8%
No HDP	18 28.6%	59 93.7%

2. Primary Outcome

Title	Numerical Pain Rating System (NRS) Pain Scores
Description	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.
Time Frame	Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Block (ISB)	Superior Trunk Block (STB)
Arm/Group Description	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	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
Measure Participants	63	62
Median (Inter-Quartile Range) [units on a scale]	0	0

3. Secondary Outcome

Title	Block Duration
Description	Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
Time Frame	Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Block (ISB)	Superior Trunk Block (STB)
Arm/Group Description	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	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
Measure Participants	57	61
Median (Inter-Quartile Range) [Hours]	23.18	23.15

Adverse Events

Time Frame	From Post Op Day 1 to Post Op Day 7
Adverse Event Reporting Description	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.
Arm/Group Title	Interscalene Block (ISB)		Superior Trunk Block (STB)
Arm/Group Description	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		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
All Cause Mortality
	Interscalene Block (ISB)		Superior Trunk Block (STB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)
Serious Adverse Events
	Interscalene Block (ISB)		Superior Trunk Block (STB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Interscalene Block (ISB)		Superior Trunk Block (STB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.