Phase 4
N=51
Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Full-thickness Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT02462382 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Mean Visual Analog Scale — 3.5; 5.9; 3.1; 5.2 units on a scale — p=.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Arthroscopic Rotator Cuff Repair (Procedure); Ropivacaine (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orlando Health, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Visual Analog Scale |
3.5; 5.9; 3.1; 5.2; 4.0; 5.4 | .006 sig |
| SECONDARY Mean Visual Analog Scale Score |
3.5; 3.3; 3.3; 3.1; 3.2; 3.4 | — |
| SECONDARY Oxycodone Consumption |
5.8; 8.3; 5.8; 7.9 | — |
| SECONDARY Oxycodone Consumption After the First Two Postoperative Days. |
5.5; 5.8; 3.9; 4.7; 3.6; 3.7 | — |
Summary
Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very painful when the block wears off. The purpose of this study is to:
1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair.
2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair.
3. Evaluate for any continued pain relief benefit of continuous infusion scalene block ropivacaine catheters during the three days after the infusion catheters have finished.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Prior surgery on the involved shoulder
- Preoperative MRI suggesting that the rotator cuff tear is irreparable
- Patients with known allergies to oxycodone, ropivacaine or a similar drug
- Workman's compensation patients
- Patients who do not fill out their visual analog scores or their medication diaries
- Patients with labral or subscapularis tears requiring repair
Data sourced from ClinicalTrials.gov (NCT02462382). 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.