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

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

    • Connecticut
      • Hartford, Connecticut, United States, 06057
        • Saint Francis Hospital and Medical Center

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
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
during hospital stay (average 3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative anxiety scores
Time Frame: preoperative
Analysis of preoperative anxiety scores.
preoperative
Preoperative depression scores
Time Frame: preoperative
Analysis of preoperative depression score.
preoperative

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.

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

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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