NCT01151241

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

4.1 years

First QC Date

June 24, 2010

Last Update Submit

February 20, 2015

Conditions

Elbow Arthroscopy Surgery

Keywords

elbow surgeryinfraclavicular nerve blockcontinuous passive motionultrasound guided regional anesthesiaearly discharge

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    Range of motion at the elbow will be measured vs. baseline to determine surgical success.

    1 year

Secondary Outcomes (1)

  • Post-operative analgesia

    3 days

Study Arms (2)

Early discharge

EXPERIMENTAL

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.Other: Early Discharge

Normal Discharge

ACTIVE COMPARATOR

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.Other: Normal Discharge

Interventions

Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.PROCEDURE

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.

Early dischargeNormal Discharge
Early DischargeOTHER

Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.

Early discharge
Normal DischargeOTHER

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.

Normal Discharge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • Anahi Perlas, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 28, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

CA(1)