Trial Outcomes & Findings for Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion (NCT NCT01126593)
NCT ID: NCT01126593
Last Updated: 2014-11-07
Results Overview
Pain was measured via Visual Analong Scale in measurement (0-100mm).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.
Results posted on
2014-11-07
Participant Flow
Principal investigator recruited patients in clinic.
If patient met the inclusion criteria and agreed to participate, they were given the consent to sign and were randomized into the trial.
Participant milestones
| Measure |
Placebo Group
The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
|
Control Group
The control group patients will receive no continuous infusion catheter.
|
Study Group
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
29
|
34
|
|
Overall Study
COMPLETED
|
29
|
27
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Baseline characteristics by cohort
| Measure |
Placebo Group
n=29 Participants
The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
|
Control Group
n=27 Participants
The control group patients will receive no continuous infusion catheter.
|
Study Group
n=32 Participants
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 0.9 • n=99 Participants
|
58 years
STANDARD_DEVIATION 0.6 • n=107 Participants
|
56 years
STANDARD_DEVIATION 0.8 • n=206 Participants
|
57 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
27 participants
n=107 Participants
|
32 participants
n=206 Participants
|
88 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.Pain was measured via Visual Analong Scale in measurement (0-100mm).
Outcome measures
| Measure |
Placebo Group
n=29 Participants
The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
|
Control Group
n=27 Participants
The control group patients will receive no continuous infusion catheter.
|
Study Group
n=32 Participants
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
|
|---|---|---|---|
|
Pain Scores
Pain at baseline
|
64.7 mm
Standard Deviation 25.9
|
43.9 mm
Standard Deviation 33.6
|
51.4 mm
Standard Deviation 31.1
|
|
Pain Scores
Pain at 1 hour
|
60 mm
Standard Deviation 19.5
|
59.7 mm
Standard Deviation 26.5
|
52.3 mm
Standard Deviation 25.8
|
|
Pain Scores
Pain at 2 hours
|
60.5 mm
Standard Deviation 23.2
|
62 mm
Standard Deviation 26.0
|
50.7 mm
Standard Deviation 24.2
|
|
Pain Scores
Pain at 3 hours
|
60 mm
Standard Deviation 24.5
|
55.3 mm
Standard Deviation 27.1
|
51.2 mm
Standard Deviation 27.6
|
|
Pain Scores
Pain at 4 hours
|
52.6 mm
Standard Deviation 26.5
|
50.3 mm
Standard Deviation 28.7
|
46.8 mm
Standard Deviation 27.3
|
|
Pain Scores
Pain at 5 hours
|
54.5 mm
Standard Deviation 25.5
|
48.6 mm
Standard Deviation 24.1
|
46.7 mm
Standard Deviation 33.2
|
|
Pain Scores
Pain at 6 hours
|
42.9 mm
Standard Deviation 26.6
|
37.3 mm
Standard Deviation 22.3
|
42.2 mm
Standard Deviation 32.0
|
|
Pain Scores
Pain at 12 hours
|
46.6 mm
Standard Deviation 28.0
|
35.8 mm
Standard Deviation 22.7
|
42.8 mm
Standard Deviation 29.0
|
|
Pain Scores
Pain at 72 hours
|
45.0 mm
Standard Deviation 18.7
|
41.1 mm
Standard Deviation 18.1
|
42.7 mm
Standard Deviation 19.2
|
Adverse Events
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Group
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
Restriction type: GT60