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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01907178
Other study ID # 13-06-002
Secondary ID
Status Completed
Phase N/A
First received June 28, 2013
Last updated April 26, 2017
Start date July 2014
Est. completion date June 16, 2015

Study information

Verified date April 2017
Source Saint Francis Care
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 16, 2015
Est. primary completion date June 16, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients undergoing total knee arthroplasty

Exclusion Criteria:

- Patients attending rehabilitation facilities after discharge

- unwilling or unable to provide consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Saint Francis Hospital and Medical Center Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Pain medication consumption pain medication consumption will be collected during hospital stay during hospital stay (average 3 days)
Primary Pain scores Pain scores (at rest & with exercise) will be collected during the hospital stay during hospital stay (average 3 days)
Secondary preoperative anxiety scores Analysis of preoperative anxiety scores. preoperative
Secondary Preoperative depression scores Analysis of preoperative depression score. preoperative
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