Postoperative ComplicationsNCT03309644
Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery
An observational study of Postoperative Complications, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 Ottawa, Ontario. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Peripheral nerve blockade and No peripheral nerve blockade
- How many people
- 1,623 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This will be a retrospective, population-based, cohort study based in Ottawa, Ontario, Canada.
Who may be able to join
- Ontario residents
- Aged 18 years and older
- Elective ambulatory shoulder surgery
Who cannot join
- Emergency Surgery
Trial locations and contacts
1 site in 1 country.
About this study
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 Ottawa, Ontario.
Read the detailed description
The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.
- Conditions
- Postoperative Complications
- Being tested
- Peripheral nerve blockade, No peripheral nerve blockade
- Keywords
- Unplanned admissions, Visits to the ED, Readmissions, Death
- Medical subject headings
- Postoperative Complications, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blockadeOther
Participants who receive a peripheral nerve block identified through the medical chart.
No peripheral nerve blockadeOther
Participants who did not receive a peripheral nerve block identified through the medical chart.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve block | Peripheral nerve block Receives: Other: Peripheral nerve blockade | |
| No peripheral nerve block | No peripheral nerve block Receives: Other: No peripheral nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication
Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause.
Measured: From day of surgery to 30 days after surgery
Secondary outcomes (1)
Health System Costs in the 30 Days After Surgery
Calculated using validated algorithms
Measured: From day of surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study startApr 2011
- Primary completionDec 2016
- Study completionDec 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- 1,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I McIsaac, MD, MPH, Principal investigator, Department of Anesthesiology and Pain Medicine, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309644
- Sponsor's protocol ID
- GMH1
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2017
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamilton GM, Ramlogan R, Lui A, McCartney CJL, Abdallah F, McIsaac DI. Association of peripheral nerve blocks with postoperative outcomes in ambulatory shoulder surgery patients: a single-centre matched-cohort study. Can J Anaesth. 2019 Jan;66(1):63-74. doi: 10.1007/s12630-018-1234-8. Epub 2018 Oct 17.
PubMed 30334192
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03309644
- Acronym / sponsor ID
- GMH1
- Conditions
- Postoperative Complications
- Keywords
- Unplanned admissions, Visits to the ED, Readmissions, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,623 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Posted 6 Jan 2025
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 Ottawa, Ontario.
Detailed description
The investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. A multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve block | – | Other: Peripheral nerve blockadePeripheral nerve block |
| No peripheral nerve block | – | Other: No peripheral nerve blockadeNo peripheral nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a retrospective, population-based, cohort study based in Ottawa, Ontario, Canada.
Key inclusion criteria (3 listed)
- Ontario residents
- Aged 18 years and older
- Elective ambulatory shoulder surgery
Key exclusion criteria (1 listed)
- Emergency Surgery
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 |
|---|---|---|
| Peripheral nerve blockadeParticipants who receive a peripheral nerve block identified through the medical chart. | Other | Peripheral nerve block |
| No peripheral nerve blockadeParticipants who did not receive a peripheral nerve block identified through the medical chart. | Other | No peripheral nerve block |
Primary outcome
Postoperative Complication
Time frame: From day of surgery to 30 days after surgery
Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause.
1 secondary outcome
Health System Costs in the 30 Days After Surgery
Time frame: From day of surgery to 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30334192Hamilton GM, Ramlogan R, Lui A, McCartney CJL, Abdallah F, McIsaac DI. Association of peripheral nerve blocks with postoperative outcomes in ambulatory shoulder surgery patients: a single-centre matched-cohort study. Can J Anaesth. 2019 Jan;66(1):63-74. doi: 10.1007/s12630-018-1234-8. Epub 2018 Oct 17.
- 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 I McIsaac, MD, MPH principal investigator
Department of Anesthesiology and Pain Medicine, University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Ottawa Hospital Research Institute 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 3 inclusion and 1 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 6 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2025). 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 Complication (time frame: From day of surgery to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309644, which also lists 1 linked publication.
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 6 Jan 2025.