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

NCT ID: NCT01355757

Last Updated: 2014-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Rotator Cuff Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Baxter INFUSOR System

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

Group Type EXPERIMENTAL

Single Injection of Local Anesthetic

Intervention Type DRUG

Single injection of 20 ml ropivacaine 0.5%

Single Injection of Local Anesthetic

Single injection of 20 ml ropivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Baxter INFUSOR System

Intervention Type DEVICE

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

Interventions

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Baxter INFUSOR System

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

Intervention Type DEVICE

Single Injection of Local Anesthetic

Single injection of 20 ml ropivacaine 0.5%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Admir Hadzic

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Admir Hadzic, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

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St. Luke's-Roosevelt Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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10-142

Identifier Type: -

Identifier Source: org_study_id

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