Trial Outcomes & Findings for Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block (NCT NCT02424630)
NCT ID: NCT02424630
Last Updated: 2020-08-27
Results Overview
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
1, 3, 6, 12, 18, 24, 36, 48h
Results posted on
2020-08-27
Participant Flow
Rotator cuff tears were diagnosed by preoperative MRI, and the size of the rotator cuff was confirmed at the time of surgery. The indication for surgery was a symptomatic full thickness rotator cuff tear or a \> 50% thickness partial thickness rotator cuff tear. From Aug 2013 to Jul 2014, the recruitment was done at Orthopeic department.
Assessed for eligibility (n= 54) Excluded (n= 2) previous fracture history of affected shoulder (n= 1) previous cerebral palsy history involving affected shoulder(n= 1) preassignment(n=52)
Participant milestones
| Measure |
ISB With SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist.
|
ISB Alone
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
ISB With SSNB
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist.
|
ISB Alone
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
|
|---|---|---|
|
Overall Study
No rotator cuff tear
|
1
|
2
|
|
Overall Study
Open procedure
|
0
|
1
|
Baseline Characteristics
Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block
Baseline characteristics by cohort
| Measure |
ISB With SSNB
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
Arthroscopy-guided SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist.
|
ISB Alone
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
Ultrasound-guided ISB: ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
Placebo
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 3, 6, 12, 18, 24, 36, 48hThe VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
Outcome measures
| Measure |
ISB With SSNB
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
|
ISB Alone
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
|
|---|---|---|
|
Visual Analog Scale (VAS) Pain Score
1h
|
2.0 units on a scale
Standard Deviation 1.2
|
2.6 units on a scale
Standard Deviation 1.4
|
|
Visual Analog Scale (VAS) Pain Score
3h
|
1.7 units on a scale
Standard Deviation 1.0
|
2.6 units on a scale
Standard Deviation 1.4
|
|
Visual Analog Scale (VAS) Pain Score
6h
|
1.6 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 2.2
|
|
Visual Analog Scale (VAS) Pain Score
12h
|
3.5 units on a scale
Standard Deviation 1.9
|
5.8 units on a scale
Standard Deviation 1.5
|
|
Visual Analog Scale (VAS) Pain Score
18h
|
3.6 units on a scale
Standard Deviation 1.7
|
5.2 units on a scale
Standard Deviation 1.6
|
|
Visual Analog Scale (VAS) Pain Score
24h
|
3.2 units on a scale
Standard Deviation 1.7
|
4.2 units on a scale
Standard Deviation 1.5
|
|
Visual Analog Scale (VAS) Pain Score
36h
|
2.1 units on a scale
Standard Deviation 1.1
|
2.7 units on a scale
Standard Deviation 1.0
|
|
Visual Analog Scale (VAS) Pain Score
48h
|
1.3 units on a scale
Standard Deviation 0.8
|
2.0 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18, 24, 36, 48hThe SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.
Outcome measures
| Measure |
ISB With SSNB
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
|
ISB Alone
n=24 Participants
During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
|
|---|---|---|
|
Patient Satisfaction (SAT) Score
48h
|
8.5 units on a scale
Standard Deviation 0.6
|
8.2 units on a scale
Standard Deviation 0.9
|
|
Patient Satisfaction (SAT) Score
1h
|
7.9 units on a scale
Standard Deviation 1.3
|
7.2 units on a scale
Standard Deviation 1.4
|
|
Patient Satisfaction (SAT) Score
3h
|
7.8 units on a scale
Standard Deviation 1.1
|
7.3 units on a scale
Standard Deviation 1.4
|
|
Patient Satisfaction (SAT) Score
6h
|
7.8 units on a scale
Standard Deviation 1.0
|
6.0 units on a scale
Standard Deviation 1.9
|
|
Patient Satisfaction (SAT) Score
12h
|
6.2 units on a scale
Standard Deviation 1.4
|
4.3 units on a scale
Standard Deviation 1.4
|
|
Patient Satisfaction (SAT) Score
18h
|
6.4 units on a scale
Standard Deviation 1.3
|
5.1 units on a scale
Standard Deviation 1.5
|
|
Patient Satisfaction (SAT) Score
24h
|
6.9 units on a scale
Standard Deviation 1.2
|
5.9 units on a scale
Standard Deviation 1.7
|
|
Patient Satisfaction (SAT) Score
36h
|
7.9 units on a scale
Standard Deviation 1.1
|
7.1 units on a scale
Standard Deviation 1.2
|
Adverse Events
ISB With SSNB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ISB Alone
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place