Trial Outcomes & Findings for Interscalene Block Versus Superior Trunk Block (NCT NCT03272139)
NCT ID: NCT03272139
Last Updated: 2022-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
126 participants
Primary outcome timeframe
Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interscalene Block Versus Superior Trunk Block
Baseline characteristics by cohort
| Measure |
Interscalene Block (ISB)
n=63 Participants
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
|
Superior Trunk Block (STB)
n=63 Participants
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
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
n=5 Participants
|
51.5 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
BMI
|
26.8 kg/m^2
n=5 Participants
|
27.2 kg/m^2
n=7 Participants
|
26.8 kg/m^2
n=5 Participants
|
|
Length of Surgery
|
46.0 minutes
n=5 Participants
|
49.0 minutes
n=7 Participants
|
48 minutes
n=5 Participants
|
|
ASA Class
ASA 1
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
ASA Class
ASA 2
|
44 participants
n=5 Participants
|
52 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
ASA Class
ASA 3
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Laterality
LEFT Shoulder Arthroscopy
|
28 participants
n=5 Participants
|
23 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Laterality
Right Shoulder Arthroscopy
|
35 participants
n=5 Participants
|
40 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Baseline NRS
|
2.0 units on a scale
n=5 Participants
|
2.0 units on a scale
n=7 Participants
|
2.0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readersOur 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.
Outcome measures
| Measure |
Interscalene Block (ISB)
n=63 Participants
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
|
Superior Trunk Block (STB)
n=62 Participants
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
|
|---|---|---|
|
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
HDP
|
45 participants
|
3 participants
|
|
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
No HDP
|
18 participants
|
59 participants
|
PRIMARY outcome
Timeframe: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring SystemNumerical 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.
Outcome measures
| Measure |
Interscalene Block (ISB)
n=63 Participants
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
|
Superior Trunk Block (STB)
n=62 Participants
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
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Interscalene Block (ISB)
n=57 Participants
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
|
Superior Trunk Block (STB)
n=61 Participants
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
|
|---|---|---|
|
Block Duration
|
23.18 Hours
Interval 19.95 to 25.53
|
23.15 Hours
Interval 19.12 to 30.07
|
Adverse Events
Interscalene Block (ISB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Superior Trunk Block (STB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Kim
Department of Anesthesiology, Critical Care & Pain Management
Phone: 212-606-1206
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place