Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks

NCT02462382 | Completed Phase 4 Results

• 1 other identifier: 13.121.08
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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. 1.Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair.
2. 2.Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair.
3. 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.

Conditions

Full-thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Mean Visual Analog Scale Score

  Post Operative Days (POD) 3, 4 and 5.

• Oxycodone Consumption

  Post operative days 1 and 2.

• Oxycodone Consumption After the First Two Postoperative Days.

  Post Operative Days 3, 4 and 5.

Study Arms (2)

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.

Procedure: Arthroscopic Rotator Cuff Repair; Drug: Ropivacaine

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.

Procedure: Arthroscopic Rotator Cuff Repair; Drug: Saline

Interventions

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.

Also known as: Shoulder arthroscopy

Ropivacaine infusion; Saline infusion

Ropivacaine DRUG

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

Also known as: Study drug

Ropivacaine infusion

Saline DRUG

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

Also known as: Placebo

Saline infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Orthopaedic Center

Orlando, Florida, 32806, United States

Location

MeSH Terms

Interventions

Ropivacaine; Drug Evaluation; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Development; Investigative Techniques; Evaluation Studies as Topic; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Randy Schwartzberg, MD
• Organization: Orlando Orthopaedic Center

orlandosportsdoc@yahoo.com

407-254-2500

Study Officials

• Randy Schwartzberg, MD

  Orlando Orthopedic Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 4, 2015
• Study Start: September 1, 2013
• Primary Completion: May 20, 2016
• Study Completion: May 20, 2016
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-11

Locations

US (1)