Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks

NCT ID: NCT02462382

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2016-05-20

Brief 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.

Detailed Description

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.

Conditions

Full-thickness Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Arthroscopic Rotator Cuff Repair

Intervention Type: 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.

Ropivacaine

Intervention Type: DRUG

The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.

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.

Group Type: PLACEBO_COMPARATOR

Arthroscopic Rotator Cuff Repair

Intervention Type: 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.

Saline

Intervention Type: DRUG

The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.

Interventions

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.

Intervention Type: PROCEDURE

Ropivacaine

The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.

Intervention Type: DRUG

Saline

The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.

Intervention Type: DRUG

Other Intervention Names

Shoulder arthroscopy; Study drug; Placebo

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

1. Prior surgery on the involved shoulder

2. Preoperative MRI suggesting that the rotator cuff tear is irreparable

3. Patients with known allergies to oxycodone, ropivacaine or a similar drug

4. Workman's compensation patients

5. Patients who do not fill out their visual analog scores or their medication diaries

6. Patients with labral or subscapularis tears requiring repair

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orlando Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Paula J. Harriott

Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randy Schwartzberg, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Orthopedic Center

Locations

Orlando Orthopaedic Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

13.121.08

Identifier Type: -

Identifier Source: org_study_id