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Pain and Function After Orthopedic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
James C. Eisenach, M.D., Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01390298
First received: July 6, 2011
Last updated: May 28, 2014
Last verified: May 2014
  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 Wake Forest School of Medicine:

Primary Outcome Measures:
  • Self-reported pain intensity [ Time Frame: Hospital Discharge to day 168 ] [ Designated as safety issue: No ]

    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: February 2015
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Medicine
Investigators
Principal Investigator: James C Eisenach, M.D. Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: James C. Eisenach, M.D., Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01390298     History of Changes
Other Study ID Numbers: IRB00017394
Study First Received: July 6, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
chronic pain after knee replacement surgery

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

ClinicalTrials.gov processed this record on November 20, 2014