Trial Outcomes & Findings for Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks (NCT NCT02462382)
NCT ID: NCT02462382
Last Updated: 2020-12-22
Results Overview
Shoulder Pain as measured by Visual Analog Scale, score 0-10. 0 equals no pain, 10 equals severe pain. Data not available for each tear size, all attempts were made to locate.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
During the first two Post Operative Days.
Results posted on
2020-12-22
Participant Flow
Potential subjects were asked to participate during their clinic visits.
Participant milestones
| Measure |
Ropivacaine Infusion
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ropivacaine Infusion
n=24 Participants
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
n=27 Participants
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=24 Participants
|
26 Participants
n=27 Participants
|
49 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=24 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=24 Participants
|
9 Participants
n=27 Participants
|
18 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=24 Participants
|
18 Participants
n=27 Participants
|
33 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Mean Visual Analog Scale Score
POD 0 1cm incision
|
0.3 Units on a scale
n=24 Participants
|
0 Units on a scale
n=27 Participants
|
0.3 Units on a scale
n=51 Participants
|
|
Mean Visual Analog Scale Score
POD 0 2cm incision
|
0.9 Units on a scale
n=24 Participants
|
0.8 Units on a scale
n=27 Participants
|
0.85 Units on a scale
n=51 Participants
|
|
Mean Visual Analog Scale Score
POD 0 3cm incision
|
0.23 Units on a scale
n=24 Participants
|
0.24 Units on a scale
n=27 Participants
|
0.23 Units on a scale
n=51 Participants
|
PRIMARY outcome
Timeframe: During the first two Post Operative Days.Population: The study did not compare patients based on tear/incision size. All attempts were made to locate this data but it is unavailable.
Shoulder Pain as measured by Visual Analog Scale, score 0-10. 0 equals no pain, 10 equals severe pain. Data not available for each tear size, all attempts were made to locate.
Outcome measures
| Measure |
Ropivacaine Infusion
n=24 Participants
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
n=27 Participants
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
|---|---|---|
|
Mean Visual Analog Scale
POD1 1cm incision
|
3.5 units on a scale
Interval 2.2 to 4.8
|
5.9 units on a scale
Interval 5.0 to 6.9
|
|
Mean Visual Analog Scale
POD 1 2cm incision
|
3.1 units on a scale
Interval 2.1 to 4.2
|
5.2 units on a scale
Interval 4.3 to 6.1
|
|
Mean Visual Analog Scale
POD 1 3cm incision
|
4.0 units on a scale
Interval 2.8 to 5.1
|
5.4 units on a scale
Interval 4.4 to 6.3
|
|
Mean Visual Analog Scale
POD 2 1cm incision
|
2.9 units on a scale
Interval 1.8 to 4.0
|
4.0 units on a scale
Interval 3.0 to 4.9
|
|
Mean Visual Analog Scale
POD 2 2cm incision
|
3.1 units on a scale
Interval 1.8 to 4.3
|
3.6 units on a scale
Interval 2.5 to 4.7
|
|
Mean Visual Analog Scale
POD 2 3 cm incision
|
3.8 units on a scale
Interval 2.8 to 4.9
|
4.1 units on a scale
Interval 3.1 to 5.1
|
SECONDARY outcome
Timeframe: Post Operative Days (POD) 3, 4 and 5.Population: All attempts were made to locate the data for the number of participants with different incision/tear sizes, but the data are not available.
Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain.
Outcome measures
| Measure |
Ropivacaine Infusion
n=24 Participants
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
n=27 Participants
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
|---|---|---|
|
Mean Visual Analog Scale Score
POD 3 3cm incision
|
3.2 units on a scale
Interval 2.2 to 4.2
|
3.4 units on a scale
Interval 2.4 to 4.4
|
|
Mean Visual Analog Scale Score
POD 3 1cm incision
|
3.5 units on a scale
Interval 2.3 to 4.6
|
3.3 units on a scale
Interval 2.3 to 4.3
|
|
Mean Visual Analog Scale Score
POD 3 2cm incision
|
3.3 units on a scale
Interval 2.2 to 4.4
|
3.1 units on a scale
Interval 2.4 to 4.4
|
|
Mean Visual Analog Scale Score
POD 4 1 cm incision
|
2.6 units on a scale
Interval 1.6 to 3.7
|
3.5 units on a scale
Interval 2.5 to 4.5
|
|
Mean Visual Analog Scale Score
POD 4 2cm incision
|
2.6 units on a scale
Interval 1.5 to 3.7
|
3.2 units on a scale
Interval 2.3 to 4.1
|
|
Mean Visual Analog Scale Score
POD 4 3cm incision
|
2.8 units on a scale
Interval 1.6 to 4.1
|
3.3 units on a scale
Interval 2.4 to 4.3
|
|
Mean Visual Analog Scale Score
POD 5 1cm incision
|
2.3 units on a scale
Interval 1.4 to 3.2
|
3.0 units on a scale
Interval 2.1 to 3.9
|
|
Mean Visual Analog Scale Score
POD 5 2cm incision
|
2.2 units on a scale
Interval 1.2 to 3.2
|
2.6 units on a scale
Interval 1.7 to 3.5
|
|
Mean Visual Analog Scale Score
POD 5 3cm incision
|
2.8 units on a scale
Interval 1.7 to 3.8
|
3.0 units on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Post operative days 1 and 2.Outcome measures
| Measure |
Ropivacaine Infusion
n=24 Participants
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
n=27 Participants
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
|---|---|---|
|
Oxycodone Consumption
POD 1
|
5.8 Pills
Interval 4.1 to 7.5
|
8.3 Pills
Interval 6.6 to 10.0
|
|
Oxycodone Consumption
POD 2
|
5.8 Pills
Interval 4.1 to 7.6
|
7.9 Pills
Interval 6.2 to 9.5
|
SECONDARY outcome
Timeframe: Post Operative Days 3, 4 and 5.Outcome measures
| Measure |
Ropivacaine Infusion
n=24 Participants
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Ropivacaine
|
Saline Infusion
n=27 Participants
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline.
Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
Saline
|
|---|---|---|
|
Oxycodone Consumption After the First Two Postoperative Days.
POD 3
|
5.5 Pills
Interval 3.9 to 7.0
|
5.8 Pills
Interval 4.2 to 7.5
|
|
Oxycodone Consumption After the First Two Postoperative Days.
POD 4
|
3.9 Pills
Interval 2.6 to 5.1
|
4.7 Pills
Interval 3.2 to 6.2
|
|
Oxycodone Consumption After the First Two Postoperative Days.
POD 5
|
3.6 Pills
Interval 2.4 to 4.8
|
3.7 Pills
Interval 2.4 to 5.1
|
Adverse Events
Ropivacaine Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Infusion
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