Arthropathy of Knee JointNCT01907178
Postoperative Pain Management in Hospital and Following Discharge From Hospital.
An observational study of Arthropathy of Knee Joint, run by Trinity Health Of New England at 1 site in United States.
Trial summary
To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthropathy of Knee Joint
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 16 Jun 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at Saint Francis Hospital undergoing total knee replacement
Who may be able to join
- Patients undergoing total knee arthroplasty
Who cannot join
- Patients attending rehabilitation facilities after discharge
- unwilling or unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06057
About this study
Official title: Assessment of Postoperative Pain Management in Patients Undergoing Total Knee Arthroplasty Immediately After Surgery and Following Discharge From Hospital.
To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.
Read the detailed description
We hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. A total of 200 patients undergoing total knee surgery will be enrolled in this observational study. They will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. Following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.
- Conditions
- Arthropathy of Knee Joint
- Keywords
- total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative pain management | The postoperative pain level will be assessed during hospitalization and at home, in patients undergoing total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain scores (at rest \& with exercise) will be collected during the hospital stay
Measured: during hospital stay (average 3 days)
Secondary outcomes (2)
preoperative anxiety scores
Analysis of preoperative anxiety scores.
Measured: preoperative
Preoperative depression scores
Analysis of preoperative depression score.
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2014
- Primary completion16 Jun 2015
- Study completion16 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, MD, Principal investigator, WVU Medicine Thomas Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907178
- Sponsor's protocol ID
- 13-06-002
- Status last verified
- Apr 2017
- First submitted
- 28 Jun 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain Management in Patients Undergoing Total Knee Arthroplasty Immediately After Surgery and Following Discharge From Hospital.
- ClinicalTrials.gov ID
- NCT01907178
- Acronym / sponsor ID
- 13-06-002
- Conditions
- Arthropathy of Knee Joint
- Keywords
- total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 16 Jun 2015 (actual)
- Study completion
- 16 Jun 2015 (actual)
- First posted
- 24 Jul 2013 (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.
To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.
Detailed description
We hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. A total of 200 patients undergoing total knee surgery will be enrolled in this observational study. They will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. Following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative pain management | – | –The postoperative pain level will be assessed during hospitalization and at home, in patients undergoing total knee replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at Saint Francis Hospital undergoing total knee replacement
Key inclusion criteria (1 listed)
- Patients undergoing total knee arthroplasty
Key exclusion criteria (2 listed)
- Patients attending rehabilitation facilities after discharge
- unwilling or unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores
Time frame: during hospital stay (average 3 days)
Pain scores (at rest \& with exercise) will be collected during the hospital stay
2 secondary outcomes
preoperative anxiety scores
Time frame: preoperative
Preoperative depression scores
Time frame: preoperative
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 27 Apr 2017.
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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.
Sanjay Sinha, MD principal investigator
WVU Medicine Thomas Hospitals
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 Arthropathy of Knee Joint, run by Trinity Health Of New England at 1 site in United States.
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 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 Apr 2017. 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 United States. 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?
Pain scores (time frame: during hospital stay (average 3 days)). 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 Apr 2017.