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

May 16, 2014 updated by: Admir Hadzic, St. Luke's-Roosevelt Hospital Center
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Baxter INFUSOR System
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Drug: Single Injection of Local Anesthetic
Single injection of 20 ml ropivacaine 0.5%
ACTIVE_COMPARATOR: Single Injection of Local Anesthetic
Single injection of 20 ml ropivacaine 0.5%
Device: Baxter INFUSOR System
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Admir Hadzic, MD PhD, St. Luke's-Roosevelt Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (ESTIMATE)

May 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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