Elbow Arthroscopy SurgeryNCT01151241
Early Discharge in Patients Undergoing Elbow Arthroscopy
A study testing Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Early Discharge and Normal Discharge in people with Elbow Arthroscopy Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elbow Arthroscopy Surgery
- What is being tested?
- Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Early Discharge and Normal Discharge
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
- ASA I-III
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Elbow Arthroscopy Surgery
- Being tested
- Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Early Discharge, Normal Discharge
- Keywords
- elbow surgery, infraclavicular nerve block, continuous passive motion, ultrasound guided regional anesthesia, early discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.Procedure or surgery
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 DischargeOther
Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.
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.
| Study group | Role | What they receive |
|---|---|---|
| Early discharge | Experimental | Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place. Receives: 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. Receives: Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.; Other: Normal Discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Range of motion at the elbow will be measured vs. baseline to determine surgical success.
Measured: 1 year
Secondary outcomes (1)
Post-operative analgesia
Pain scores, by visual analogue scale, will be used to determine patient satisfaction with analgesia to day 3 after surgery.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Arthroscopy SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151241
- Sponsor's protocol ID
- 10-0120-A
- Status last verified
- Feb 2015
- First submitted
- 24 Jun 2010
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Versus Inpatient Continuous Brachial Plexus Block for Complex Arthroscopic Elbow Surgery: Safety and Functional Outcome
- ClinicalTrials.gov ID
- NCT01151241
- Acronym / sponsor ID
- 10-0120-A
- Conditions
- Elbow Arthroscopy Surgery
- Keywords
- elbow surgery, infraclavicular nerve block, continuous passive motion, ultrasound guided regional anesthesia, early discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early discharge | Experimental | Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Other: Early DischargePatients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place. |
| Normal Discharge | Active comparator | Procedure: Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Other: Normal DischargePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
- ASA I-III
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Early discharge, Normal Discharge |
| Early DischargePatients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place. | Other | Early discharge |
| Normal DischargePatients 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. | Other | Normal Discharge |
Primary outcome
Range of Motion
Time frame: 1 year
Range of motion at the elbow will be measured vs. baseline to determine surgical success.
1 secondary outcome
Post-operative analgesia
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anahi Perlas, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op., Early Discharge and Normal Discharge in people with Elbow Arthroscopy Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.