Pain and Function After Orthopedic Surgery

NCT01390298 | Completed Results

• 1 other identifier: IRB00017394
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

chronic pain after knee replacement surgery

Outcome Measures

Primary Outcomes (1)

• Self-reported Pain Intensity

  McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes Visual Analog Scores were obtained during the following times: Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168 Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation. The change in pain over time was modeled by 7.7344 - 1.6013(log(time))

  Day of hospital discharge to postoperative day 168

Study Arms (1)

Observational

Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate

Other: Observational

Interventions

Observational OTHER

Observational study only

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• ASA \>3

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: NONE RETAINED

Plasma

MeSH Terms

Conditions

Chronic Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Results Point of Contact

• Title: James C. Eisenach, M.D.
• Organization: Wake Forest School of Medicine

jimeisenach@gmail.com

336-716-4498

Study Officials

• James C Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 11, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2017
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)