Postoperative ComplicationsNCT03544775
Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery
An observational study of Postoperative Complications, run by Ottawa Hospital Research Institute.
Trial summary
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Isolated General Anesthesia and Peripheral Nerve Block
- Type of treatment
- Surgery or procedure
- How many people
- 59,644 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2009to 31 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Adult, Older adult
Study population: This will be a retrospective, population-based, cohort study based in Ontario, Canada. Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery. The study period extends from April 2009 to March 2016.
Who may be able to join
- Ontario residents
- Aged 18 years and older
- Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.
Who cannot join
- Emergency Surgery
- If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.
About this study
Official title: Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Ambulatory Shoulder Surgery
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.
Read the detailed description
First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.
- Conditions
- Postoperative Complications
- Being tested
- Isolated General Anesthesia, Peripheral Nerve Block
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated General AnesthesiaProcedure or surgery
Also called iGA
No nerve block identified through physician billing codes
Peripheral Nerve BlockProcedure or surgery
Also called PNB+GA
Nerve block identified through physician billing codes
| Study group | Role | What they receive |
|---|---|---|
| Isolated General Anesthesia | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. Receives: Procedure: Isolated General Anesthesia | |
| Peripheral Nerve Block | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Receives: Procedure: Peripheral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Death, Admission, Readmission or Emergency Department Visits
Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause
Measured: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first
Secondary outcomes (2)
Health System Costs
Costs in Canadian dollars will be calculated using standardized patient-level costing algorithms.
Measured: Date of surgery to 7 days and 30 days after surgery or death date, whichever came first
Neurology Consultations or Diagnostics
Occurrence of neurology consult and/or nerve conduction study
Measured: Date of surgery to 90 days after surgery or death date, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Apr 2009
- Primary completion31 Mar 2016
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel McIsaac, MD, MPH, Principal investigator, Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544775
- Sponsor's protocol ID
- GMH2
- Status last verified
- Nov 2024
- First submitted
- 8 May 2018
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Ambulatory Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03544775
- Acronym / sponsor ID
- GMH2
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59,644 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.
Detailed description
First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated General Anesthesia | – | Procedure: Isolated General AnesthesiaOntario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. |
| Peripheral Nerve Block | – | Procedure: Peripheral Nerve BlockOntario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This will be a retrospective, population-based, cohort study based in Ontario, Canada. Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery. The study period extends from April 2009 to March 2016.
Key inclusion criteria (3 listed)
- Ontario residents
- Aged 18 years and older
- Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.
Key exclusion criteria (2 listed)
- Emergency Surgery
- If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.
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 |
|---|---|---|
| Isolated General AnesthesiaAlso: iGANo nerve block identified through physician billing codes | Procedure or surgery | Isolated General Anesthesia |
| Peripheral Nerve BlockAlso: PNB+GANerve block identified through physician billing codes | Procedure or surgery | Peripheral Nerve Block |
Primary outcome
Postoperative Death, Admission, Readmission or Emergency Department Visits
Time frame: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first
Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause
2 secondary outcomes
Health System Costs
Time frame: Date of surgery to 7 days and 30 days after surgery or death date, whichever came first
Neurology Consultations or Diagnostics
Time frame: Date of surgery to 90 days after surgery or death date, whichever came first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel McIsaac, MD, MPH principal investigator
Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Ottawa Hospital Research Institute.
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 3 inclusion and 2 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Death, Admission, Readmission or Emergency Department Visits (time frame: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first). 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 27 Nov 2024.