Early Discharge in Patients Undergoing Elbow Arthroscopy

February 20, 2015 updated by: University Health Network, Toronto

Outpatient Versus Inpatient Continuous Brachial Plexus Block for Complex Arthroscopic Elbow Surgery: Safety and Functional Outcome

Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia (infraclavicular nerve block combined with general anesthesia for surgery; continuous infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group will be discharged home after one day, with infraclavicular catheter in place; patients in the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study will compare range of motion as the primary endpoint, in a non-inferiority design, to see if early discharge is feasible while providing similar recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
  • ASA I-III

Exclusion Criteria:

  • Age>65
  • Cognitively challenged patients
  • Severe COPD
  • Patients who, on their own or with the assistance of a caregiver, are not confident of being able to remove the local anesthetic infusion catheter at home
  • Psychiatric history
  • Allergy to ropivacaine.
  • Opioid tolerance (>60mg oral morphine or equivalent/day)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early discharge
Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.
Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.
Patients undergoing elbow arthroscopy surgery will receive standard anesthesia/analgesia, including infraclavicular nerve block and general anesthesia for surgery followed by infraclavicular catheter infusion of local anesthetic until day 3 after surgery.
Other: Early Discharge
Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.
Active Comparator: Normal Discharge
Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.
Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.
Patients undergoing elbow arthroscopy surgery will receive standard anesthesia/analgesia, including infraclavicular nerve block and general anesthesia for surgery followed by infraclavicular catheter infusion of local anesthetic until day 3 after surgery.
Other: Normal Discharge
Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 1 year
Range of motion at the elbow will be measured vs. baseline to determine surgical success.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative analgesia
Time Frame: 3 days
Pain scores, by visual analogue scale, will be used to determine patient satisfaction with analgesia to day 3 after surgery.
3 days

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

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

July 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0120-A

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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