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

Early Phase 1

Completed

• Conditions: Rotator Cuff Injury
• Interventions: Drug: Single Injection of Local Anesthetic; Device: Baxter INFUSOR System

• Registration Number: NCT01355757
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baxter INFUSOR System	Single Injection of Local Anesthetic	Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Single Injection of Local Anesthetic	Baxter INFUSOR System	Single injection of 20 ml ropivacaine 0.5%

Primary Outcome Measures

Name	Time	Method
Quality of Life	24 weeks	To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital; 🇺🇸 New York, New York, United States