- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01907178
Postoperative Pain Management in Hospital and Following Discharge From Hospital.
April 26, 2017 updated by: Saint Francis Care
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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Hartford, Connecticut, United States, 06057
- Saint Francis Hospital and Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated at Saint Francis Hospital undergoing total knee replacement
Description
Inclusion Criteria:
- Patients undergoing total knee arthroplasty
Exclusion Criteria:
- Patients attending rehabilitation facilities after discharge
- unwilling or unable to provide consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Postoperative pain management
The postoperative pain level will be assessed during hospitalization and at home, in patients undergoing total knee replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: during hospital stay (average 3 days)
|
Pain scores (at rest & with exercise) will be collected during the hospital stay
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during hospital stay (average 3 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
preoperative anxiety scores
Time Frame: preoperative
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Analysis of preoperative anxiety scores.
|
preoperative
|
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Preoperative depression scores
Time Frame: preoperative
|
Analysis of preoperative depression score.
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preoperative
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain medication consumption
Time Frame: during hospital stay (average 3 days)
|
pain medication consumption will be collected during hospital stay
|
during hospital stay (average 3 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, MD, Saint Francis Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 16, 2015
Study Completion (Actual)
June 16, 2015
Study Registration Dates
First Submitted
June 28, 2013
First Submitted That Met QC Criteria
July 18, 2013
First Posted (Estimate)
July 24, 2013
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-06-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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