PainNCT02742961
Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement
An observational study of Pain and Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Pain is common after knee replacement surgery and can impact a variety of patient outcomes. Peripheral nerve blocks provide improved pain control and may improve function. However, their impact on other outcomes is poorly described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Peripheral nerve block
- How many people
- 178,214 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2002to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults having their first total knee replacement during the study period
Who may be able to join
- first primary total knee replacement during the study period
Who cannot join
- Revision arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Pain is common after knee replacement surgery and can impact a variety of patient outcomes. Peripheral nerve blocks provide improved pain control and may improve function. However, their impact on other outcomes is poorly described. Therefore, this comparative effectiveness study will estimate the independent association between nerve blocks and health outcomes after knee replacement surgery.
Read the detailed description
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient and health system outcomes after elective total knee replacement surgery.
The investigators will develop a non-parsimonious propensity score to control for potential indication bias and confounding in this observational study. Using the propensity score the investigators will match patients who receive a peripheral nerve block to a patient who did not to estimate the independent association of peripheral nerve blocks with our study outcomes.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Peripheral nerve block
- Keywords
- orthopedics, anesthesiology, nerve block, length of stay, Patient readmission
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blockOther
A physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve block | Intervention arm. Participants who receive a peripheral nerve block identified through submission of an appropriate physician billing code Receives: Other: Peripheral nerve block | |
| No peripheral nerve block | Control arm. Participants who do not receive a peripheral nerve block identified through lack of a submission of an appropriate physician billing code |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Determined from the Canadian Institute for Health Information Discharge Abstract Database record for the index hospitalization
Measured: Day of surgery to day of discharge, or up to 365 days, whichever comes first
Secondary outcomes (3)
Hospital readmission
Determined from the Canadian Institute for Health Information Discharge Abstract Database through identification of a new record after discharge from the index hospitalization
Measured: The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any readmission in this time period will be considered an event.
In-hospital fall
Determined using validated International Classification of Diseases Tenth edition codes for falls from the index hospitalization Discharge Abstract Database record
Measured: hospital admission
Emergency department visit
Defined as the creation of a record in the National Ambulatory Care Reporting System for an emergency department visit that occurs after discharge and before 30 days after discharge
Measured: The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any emergency department visit in this time period will be considered an event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2002
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 178,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan McIsaac, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742961
- Sponsor's protocol ID
- DM1
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02742961
- Acronym / sponsor ID
- DM1
- Conditions
- Pain, Osteoarthritis
- Keywords
- orthopedics, anesthesiology, nerve block, length of stay, Patient readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178,214 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Apr 2016 (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.
Pain is common after knee replacement surgery and can impact a variety of patient outcomes. Peripheral nerve blocks provide improved pain control and may improve function. However, their impact on other outcomes is poorly described. Therefore, this comparative effectiveness study will estimate the independent association between nerve blocks and health outcomes after knee replacement surgery.
Detailed description
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient and health system outcomes after elective total knee replacement surgery.
The investigators will develop a non-parsimonious propensity score to control for potential indication bias and confounding in this observational study. Using the propensity score the investigators will match patients who receive a peripheral nerve block to a patient who did not to estimate the independent association of peripheral nerve blocks with our study outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve block | – | Other: Peripheral nerve blockIntervention arm. Participants who receive a peripheral nerve block identified through submission of an appropriate physician billing code |
| No peripheral nerve block | – | –Control arm. Participants who do not receive a peripheral nerve block identified through lack of a submission of an appropriate physician billing code |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults having their first total knee replacement during the study period
Key inclusion criteria (1 listed)
- first primary total knee replacement during the study period
Key exclusion criteria (1 listed)
- Revision arthroplasty
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 blockA physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus | Other | Peripheral nerve block |
Primary outcome
Hospital length of stay
Time frame: Day of surgery to day of discharge, or up to 365 days, whichever comes first
Determined from the Canadian Institute for Health Information Discharge Abstract Database record for the index hospitalization
3 secondary outcomes
Hospital readmission
Time frame: The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any readmission in this time period will be considered an event.
In-hospital fall
Time frame: hospital admission
Emergency department visit
Time frame: The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any emergency department visit in this time period will be considered an event.
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 19 Apr 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain and Osteoarthritis, 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 1 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 19 Apr 2016. 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?
Hospital length of stay (time frame: Day of surgery to day of discharge, or up to 365 days, whichever comes 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 19 Apr 2016.