Trial Outcomes & Findings for Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery (NCT NCT02741713)
NCT ID: NCT02741713
Last Updated: 2018-08-27
Results Overview
Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
6 hours post-block.
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
Interscalene Block Plus Sham Block
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
Twenty patients will receive an ultrasound guided interscalene nerve block with Solution for Injection for Interscalene Block dosed at the 6th cervical root level, per standard clinical practice. Intervention subjects will also get a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at PECS II.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Interscalene Block Plus Sham Block
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
Twenty patients will receive an ultrasound guided interscalene nerve block with Solution for Injection for Interscalene Block dosed at the 6th cervical root level, per standard clinical practice. Intervention subjects will also get a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at PECS II.
|
|---|---|---|
|
Overall Study
Surgery type changed intra-operatively
|
2
|
1
|
Baseline Characteristics
Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Interscalene Block Plus Sham Block
n=18 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
n=19 Participants
Twenty patients will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. Intervention subjects will also a PECS "Pectoralis" II using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" II Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects. Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine Solution for Injection PECS II Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2 location.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Weight (kg)
|
88.1 kg
STANDARD_DEVIATION 17.7 • n=99 Participants
|
80.7 kg
STANDARD_DEVIATION 18.2 • n=107 Participants
|
84.3 kg
STANDARD_DEVIATION 18.1 • n=206 Participants
|
|
BMI
|
28.9 kg/m^2
STANDARD_DEVIATION 4.44 • n=99 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 4.55 • n=107 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 4.55 • n=206 Participants
|
|
Surgical Side (L/R)
Left sided surgery
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Surgical Side (L/R)
Right sided surgery
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-block.Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.
Outcome measures
| Measure |
Interscalene Block Plus Sham Block
n=18 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
n=19 Participants
Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2
|
|---|---|---|
|
Post-operative Axillary Pain
|
3 units on a scale
Interval 0.0 to 5.25
|
0 units on a scale
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: Assessed 24hrs post-block on a scale from 0-10.Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.
Outcome measures
| Measure |
Interscalene Block Plus Sham Block
n=18 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
n=19 Participants
Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2
|
|---|---|---|
|
Numerical Rating Scale Pain Scores (0-10) at Rest
|
6 units on a scale
Interval 5.0 to 7.0
|
6 units on a scale
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: Assessed 24hrs post-block (yes/no)Any episodes during the first 24 hours will be recorded as a yes.
Outcome measures
| Measure |
Interscalene Block Plus Sham Block
n=18 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
n=19 Participants
Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2
|
|---|---|---|
|
Percentage of Participants With Episodes of Nausea or Vomiting
|
39 percentage of participants
|
37 percentage of participants
|
SECONDARY outcome
Timeframe: Assessed 24hrs post-block in mgRecorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU.
Outcome measures
| Measure |
Interscalene Block Plus Sham Block
n=18 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
n=19 Participants
Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2
|
|---|---|---|
|
Total Opioid Usage
|
31.6 mg
Interval 24.1 to 39.0
|
26.9 mg
Interval 21.8 to 32.0
|
SECONDARY outcome
Timeframe: Assessed 24hrs post-block in hoursPopulation: This Outcome Measure was assessed only in the Interscalene Plus PECS Blocks group
Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block.
Outcome measures
| Measure |
Interscalene Block Plus Sham Block
n=8 Participants
Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.
Interscalene Block: An interscalene block will be performed on the subjects.
Sham Block
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection in Sham Block: Lidocaine 1%
|
Interscalene Plus PECS Blocks
Twenty patients receive an ultrasound guided interscalene nerve block with Solution for Injection in Interscalene Block dosed at the upper trunk near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.
PECS "Pectoralis" 1 and 2 Blocks: An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.
Interscalene Block: An interscalene block will be performed on the subjects.
Solution for Injection in Interscalene Block: 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
Solution for Injection PECS Blocks: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2
|
|---|---|---|
|
Time From Block Placement to Onset of Axillary Pain
|
16.7 Hours
Interval 14.1 to 19.3
|
—
|
Adverse Events
Interscalene Block Plus Sham Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interscalene Plus PECS Blocks
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