Early Discharge in Patients Undergoing Elbow Arthroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01151241
First received: June 24, 2010
Last updated: March 6, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention
Elbow Arthroscopy Surgery
Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.
Other: Early Discharge
Other: Normal Discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outpatient Versus Inpatient Continuous Brachial Plexus Block for Complex Arthroscopic Elbow Surgery: Safety and Functional Outcome

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Range of motion at the elbow will be measured vs. baseline to determine surgical success.


Secondary Outcome Measures:
  • Post-operative analgesia [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Pain scores, by visual analogue scale, will be used to determine patient satisfaction with analgesia to day 3 after surgery.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151241

Contacts
Contact: Anahi Perlas, MD 416 603-5118 anahi.perlas@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anahi Perlas, MD    416 603-5118    anahi.perlas@uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anahi Perlas, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01151241     History of Changes
Other Study ID Numbers: 10-0120-A
Study First Received: June 24, 2010
Last Updated: March 6, 2012
Health Authority: Canada: Research Ethics Board

Keywords provided by University Health Network, Toronto:
elbow surgery
infraclavicular nerve block
continuous passive motion
ultrasound guided regional anesthesia
early discharge

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014