Early Discharge in Patients Undergoing Elbow Arthroscopy

NCT ID: NCT01151241

Last Updated: 2015-02-24

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elbow Arthroscopy Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early discharge

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

Group Type EXPERIMENTAL

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

Intervention Type 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 Discharge

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Normal Discharge

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type PROCEDURE

Early Discharge

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anahi Perlas, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-0120-A

Identifier Type: -

Identifier Source: org_study_id

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