Rotator Cuff Tear
Conditions
Brief summary
Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.
Detailed description
This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study. Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.
Interventions
DRUG0.5% bupivacaine
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.
DRUGNormal Saline
The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Full thickness rotator cuff tear * Pre operative MRI * Patients who are medically stable to undergo the surgery * Patients who consent to involvement in the study
Exclusion criteria
* Prior surgery on the involved shoulder * Preoperative MRI suggesting that the rotator cuff tear is unrepairable * Patients with known allergies to oxycodone, bupivacaine or a similar drug * Workman's compensation patients * Patients who do not fill out their visual analog scores or their medication diaries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours. | Pain was measured via Visual Analong Scale in measurement (0-100mm). |
Countries
United States
Participant flow
Recruitment details
Principal investigator recruited patients in clinic.
Pre-assignment details
If patient met the inclusion criteria and agreed to participate, they were given the consent to sign and were randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Control Group The control group patients will receive no continuous infusion catheter. | 27 |
| 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. | 32 |
| Total | 88 |
Baseline characteristics
| Characteristic | Placebo Group | Control Group | Study Group | Total |
|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 0.9 | 58 years STANDARD_DEVIATION 0.6 | 56 years STANDARD_DEVIATION 0.8 | 57 years STANDARD_DEVIATION 0.8 |
| Region of Enrollment United States | 29 participants | 27 participants | 32 participants | 88 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 20 Participants | 18 Participants | 17 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 29 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 29 | 0 / 34 |
Outcome results
Primary
Pain Scores
Pain was measured via Visual Analong Scale in measurement (0-100mm).
Time frame: O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Pain Scores | Pain at 4 hours | 52.6 mm | Standard Deviation 26.5 |
| Placebo Group | Pain Scores | Pain at 5 hours | 54.5 mm | Standard Deviation 25.5 |
| Placebo Group | Pain Scores | Pain at 2 hours | 60.5 mm | Standard Deviation 23.2 |
| Placebo Group | Pain Scores | Pain at 12 hours | 46.6 mm | Standard Deviation 28 |
| Placebo Group | Pain Scores | Pain at 6 hours | 42.9 mm | Standard Deviation 26.6 |
| Placebo Group | Pain Scores | Pain at baseline | 64.7 mm | Standard Deviation 25.9 |
| Placebo Group | Pain Scores | Pain at 72 hours | 45.0 mm | Standard Deviation 18.7 |
| Placebo Group | Pain Scores | Pain at 3 hours | 60 mm | Standard Deviation 24.5 |
| Placebo Group | Pain Scores | Pain at 1 hour | 60 mm | Standard Deviation 19.5 |
| Control Group | Pain Scores | Pain at 3 hours | 55.3 mm | Standard Deviation 27.1 |
| Control Group | Pain Scores | Pain at 4 hours | 50.3 mm | Standard Deviation 28.7 |
| Control Group | Pain Scores | Pain at 6 hours | 37.3 mm | Standard Deviation 22.3 |
| Control Group | Pain Scores | Pain at 5 hours | 48.6 mm | Standard Deviation 24.1 |
| Control Group | Pain Scores | Pain at 12 hours | 35.8 mm | Standard Deviation 22.7 |
| Control Group | Pain Scores | Pain at 72 hours | 41.1 mm | Standard Deviation 18.1 |
| Control Group | Pain Scores | Pain at 1 hour | 59.7 mm | Standard Deviation 26.5 |
| Control Group | Pain Scores | Pain at 2 hours | 62 mm | Standard Deviation 26 |
| Control Group | Pain Scores | Pain at baseline | 43.9 mm | Standard Deviation 33.6 |
| Study Group | Pain Scores | Pain at 72 hours | 42.7 mm | Standard Deviation 19.2 |
| Study Group | Pain Scores | Pain at 5 hours | 46.7 mm | Standard Deviation 33.2 |
| Study Group | Pain Scores | Pain at baseline | 51.4 mm | Standard Deviation 31.1 |
| Study Group | Pain Scores | Pain at 1 hour | 52.3 mm | Standard Deviation 25.8 |
| Study Group | Pain Scores | Pain at 2 hours | 50.7 mm | Standard Deviation 24.2 |
| Study Group | Pain Scores | Pain at 12 hours | 42.8 mm | Standard Deviation 29 |
| Study Group | Pain Scores | Pain at 3 hours | 51.2 mm | Standard Deviation 27.6 |
| Study Group | Pain Scores | Pain at 6 hours | 42.2 mm | Standard Deviation 32 |
| Study Group | Pain Scores | Pain at 4 hours | 46.8 mm | Standard Deviation 27.3 |