Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

St. Luke's-Roosevelt Hospital Center

Status and phase: Completed; Early Phase 1

Conditions: Rotator Cuff Injury

Treatments: Drug: Single Injection of Local Anesthetic; Device: Baxter INFUSOR System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01355757

10-142

Details and patient eligibility

About

Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.

Inclusive criteria are:

• 18-75 years of age
• ASA physical status I-III
• BMI < 35 kg/m2

Exclusion criteria

• all open shoulder procedures
• patient having difficulty understanding the instruction on using the anesthetic infusion pump
• contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)
• significant neurologic disorders of the upper extremity
• psychiatric or cognitive disorders
• history of substance abuse or chronic opioid use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Baxter INFUSOR System

Experimental group

Description:

Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia

Treatment:

Drug: Single Injection of Local Anesthetic

Single Injection of Local Anesthetic

Active Comparator group

Description:

Single injection of 20 ml ropivacaine 0.5%

Treatment:

Device: Baxter INFUSOR System