N/A
N=156
Acute Pain Genomic Study
Osteoarthritis · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01557751 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: NRS-Pain With Movement on POD 2 — 2.83 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Whole blood for genotyping (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS-Pain With Movement on POD 2 |
2.83 | — |
Summary
In preparation for future large-scale genome wide association studies, reliable methods must be developed for measuring perceived pain and for estimating the effects of potentially confounding factors such as appropriate covariates. The major objectives of our pilot investigation are to develop optimal methods to characterize the primary endpoint of the study-knee pain, and to gather preliminary data on genetic markers in the human genome that are associated with a certain pain phenotype. The specific issues for this study will be to carry out a preliminary gene association analysis of acute perioperative pain in individuals undergoing total knee replacement and to define a pain phenotype that is composed of multidimensional domains such as opioid consumption, inflammatory markers, anxiety level, degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up changes in pain experience that can be attributed to single nucleotide polymorphisms.
Eligibility Criteria
Inclusion Criteria
- Age >18
- Undergoing a primary, unilateral total knee arthroplasty for the first time
- Willing and able to provide informed consent
- Caucasian
- Non-hispanic
Exclusion Criteria
- Contraindication or refusal for peripheral nerve blocks
- Any chronic pain condition which may confound the study per investigator's opinion
- Chronic opioid dependence per investigator's opinion
- Any diagnosis for total knee arthroplasty other than degenerative joint disease or osteoarthritis
- Evidence of clinical dementia, dementia, delirium, or any cognitive disorder which inhibits the subject's ability to comprehend and cooperate with researchers
- Revision or any knee surgery that is not a primary, unilateral, elective total knee arthroplasty being performed for the first time
- Any criteria that in the investigator's opinion would prohibit the subject from following
- Hispanic ethnicity
- Any race other than caucasian
- Subjects with knee flexion contracture (which is clinically defined for the purpose of our protocol as more than 15 degrees of knee contracture)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01557751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.