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Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks

NCT02462382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-12-22

Study results available
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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.

Conditions

  • Full-thickness Rotator Cuff Tear

Interventions

PROCEDURE

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.

DRUG

Ropivacaine

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

DRUG

Saline

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

Sponsors & Collaborators

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Randy Schwartzberg, MD · Orlando Orthopedic Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-01
Primary Completion
2016-05-20
Completion
2016-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462382 on ClinicalTrials.gov