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Pain and Function After Orthopedic Surgery

This study is currently recruiting participants.
Verified January 2017 by James C. Eisenach, M.D., Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390298
First Posted: July 11, 2011
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
James C. Eisenach, M.D., Wake Forest University Health Sciences
  Purpose

The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific explanations regarding identifying patients at risk for chronic pain after surgery and identifying mechanisms which may be altered to decrease this risk.

This study will help investigators better understand chronic pain that develops after surgery. We are proposing to study different factors related to the surgical experience and factors in the environment to determine if any play a role in the development of chronic pain after surgery.


Condition Intervention
Chronic Pain Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain and Function After Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by James C. Eisenach, M.D., Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Self-reported pain intensity [ Time Frame: Hospital Discharge to day 168 ]

    To obtain estimates of pain intensity, we will use the McGill Pain Questionnaire - Short Form (MPQ).

    The questionnaire will be completed as follows:

    3 times/day: Hospital discharge through day 14 Once daily: Day 15 through day 28 Once weekly: Day 29 through day 85 Once monthly: Day 86 through day 168



Biospecimen Retention:   Samples With DNA
Plasma

Estimated Enrollment: 75
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Knee replacement
Adult patients scheduled for elective unicompartmental or total knee replacement surgery
Other: Observational
Observational study only

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients scheduled for elective unicompartmental, total knee replacement or total hip replacement surgery, will be included. Patients will be American Society of Anesthesiologists physical status 1, 2, or 3.
Criteria

Inclusion Criteria

  • American Society of Anesthesiologist (ASA) physical status 1, 2, or 3
  • Scheduled for a total knee replacement or unicompartmental knee replacement

Exclusion Criteria:

  • ASA >3
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390298


Contacts
Contact: Regina Curry, RN 336-716-4294 recurry@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston Salem, North Carolina, United States, 27157
Principal Investigator: James C Eisenach, M.D.         
Sub-Investigator: Scott A Miller, M.D.         
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: James C Eisenach, M.D. Wake Forest University Health Sciences
  More Information

Responsible Party: James C. Eisenach, M.D., Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01390298     History of Changes
Other Study ID Numbers: IRB00017394
First Submitted: July 6, 2011
First Posted: July 11, 2011
Last Update Posted: November 17, 2017
Last Verified: January 2017

Keywords provided by James C. Eisenach, M.D., Wake Forest University Health Sciences:
chronic pain after knee replacement surgery

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms