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OpenTrials
Completed

NCT Number: NCT01355757

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

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

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

St. Luke's-Roosevelt Hospital

New York, 10025, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baxter INFUSOR System

Device

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

Single Injection of Local Anesthetic

Drug

Single injection of 20 ml ropivacaine 0.5%

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 18, 2011
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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