Acute Pain Genomic Study
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01557751|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2012
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Postoperative Pain||Genetic: Whole blood for genotyping||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Studies for Whole Genome Association Study (WGAS) in Acute Perioperative Pain|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||July 2018|
Total knee arthroplasty subjects who are genotyped
All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc).
Genetic: Whole blood for genotyping
This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
- NRS-Pain With Movement on POD 2 [ Time Frame: Postoperative day (POD) 2 ]
The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here).
Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement
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): NCT01557751
|United States, Pennsylvania|
|UPMC Presbyterian Shadyside|
|Pittsburgh, Pennsylvania, United States, 15232|