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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:
Patients undergoing arthroscopic rotator cuff repair by one of the three attending surgeon authors at Orlando Orthopaedic Outpatient Surgery Center will be candidates for the study. Further inclusion criteria will be a full-thickness rotator cuff tear, age eighteen or greater, a reparable rotator cuff tear and willingness to consent to study participation. Patients will not be excluded for concomitant procedures such as acromioplasty, distal clavicle resection, biceps tenotomy and biceps tenodesis.
Exclusion criteria will include age less than eighteen, irreparable rotator cuff tear, subscapularis tear requiring repair, labral tear requiring repair, allergy to ropivacaine or a similar local anesthetic agent and allergy to oxycodone.
All patients will undergo an ultrasound guided ISB with 30cc of 0.5% ropivacaine with epinephrine in the preoperative holding area by an anesthesiologist trained in regional block anesthesia. A continuous infusion catheter will be placed under ultrasound guidance to confirm appropriate position. An adhesive dressing on the skin will be used to keep the catheter in position and away from the operating field.
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. Randomization will be performed by block number randomization and the group assignments will be placed in sealed envelopes. The envelopes will be opened by the operating room circulating nurse. Both patients and surgeons will be blinded to the randomization.
Patients and their families will be educated preoperative and postoperative on the removal of the pain catheters. There will be written instructions regarding catheter removal. Patients or their family members will remove the catheters after the reservoirs are empty. The study authors will be available to assist with any catheter removal issues that the patients may have.
Patients will be prescribed oxycodone 5mg tablets for their postoperative pain control. Patients will receive diaries to record their pain levels utilizing visual analog scores (VAS) for the first five postoperative days. The first pain level will be recorded in the post anesthesia care unit. Pain levels will then be recorded twice daily. Patients will also be asked to log their oxycodone use during the first five postoperative days. Patients will be educated preoperative on the postoperative diaries. They will also receive a call from an OOOSC nurse on postoperative day one to address any questions or concerns.
Patients will be evaluated in the office by the operating surgeon at one week postoperative. At that time, study diaries will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine infusion | Active Comparator | 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. |
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| Saline infusion | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Rotator Cuff Repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analog Scale | 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. | During the first two Post Operative Days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analog Scale Score | Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain. | Post Operative Days (POD) 3, 4 and 5. |
| Oxycodone Consumption | Post operative days 1 and 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Schwartzberg, MD | Orlando Orthopedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Orthopaedic Center | Orlando | Florida | 32806 | United States |
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Potential subjects were asked to participate during their clinic visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Visual Analog Scale | 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. | The study did not compare patients based on tear/incision size. All attempts were made to locate this data but it is unavailable. | Posted | Mean | Full Range | units on a scale | During the first two Post Operative Days. |
|
Each patient will be part of the study for a period of five days postoperatively. Adverse event data will be collected from the time of consent until 5 days post op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This study did not specifically compare patients based on incision size/tear size. Pain scores were never compared between tear size or incision size groups. All attempts were made to locate the data but it is not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Schwartzberg, MD | Orlando Orthopaedic Center | 407-254-2500 | orlandosportsdoc@yahoo.com |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004341 | Drug Evaluation |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist. |
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| Saline | Drug | The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist. |
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| Oxycodone Consumption After the First Two Postoperative Days. | Post Operative Days 3, 4 and 5. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Mean Visual Analog Scale Score | Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain. Post Operation Day zero (POD 0) equals immediately after surgery. POD 1 equals the first day after surgery, POD 2 equals the second day after surgery. POD 3, all the way to POD 5 which is the 5th day after surgery. This study did not specifically compare patients based on incision/tear size. All attempts were made to locate the data but it is not available. | Mean | Full Range | Units on a scale |
|
| OG001 | 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 |
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| Secondary | Mean Visual Analog Scale Score | Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain. | All attempts were made to locate the data for the number of participants with different incision/tear sizes, but the data are not available. | Posted | Mean | Full Range | units on a scale | Post Operative Days (POD) 3, 4 and 5. |
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| Secondary | Oxycodone Consumption | Posted | Mean | Full Range | Pills | Post operative days 1 and 2. |
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| Secondary | Oxycodone Consumption After the First Two Postoperative Days. | Posted | Mean | Full Range | Pills | Post Operative Days 3, 4 and 5. |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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 | 0 | 27 | 0 | 27 | 0 | 27 |
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| D000588 |
| Amines |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| POD 3 3cm incision |
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| POD 4 1 cm incision |
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| POD 4 2cm incision |
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| POD 4 3cm incision |
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| POD 5 1cm incision |
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| POD 5 2cm incision |
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| POD 5 3cm incision |
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| POD 5 |
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