N/A
N=96
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT01126593 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Pain Scores — 64.7; 43.9; 51.4; 60 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.5% bupivacaine (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orlando Health, Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores |
64.7; 43.9; 51.4; 60; 59.7; 52.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01126593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.