- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557751
Acute Pain Genomic Study
Preliminary Studies for Whole Genome Association Study (WGAS) in Acute Perioperative Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Presbyterian Shadyside
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Postoperative day (POD) 2
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Collaborators and Investigators
Publications and helpful links
General Publications
- Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum In: Pain. 2006 Nov;125(1-2):197.
- Silverman DG, O'Connor TZ, Brull SJ. Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993 Jul;77(1):168-70. No abstract available.
- Tegeder I, Costigan M, Griffin RS, Abele A, Belfer I, Schmidt H, Ehnert C, Nejim J, Marian C, Scholz J, Wu T, Allchorne A, Diatchenko L, Binshtok AM, Goldman D, Adolph J, Sama S, Atlas SJ, Carlezon WA, Parsegian A, Lotsch J, Fillingim RB, Maixner W, Geisslinger G, Max MB, Woolf CJ. GTP cyclohydrolase and tetrahydrobiopterin regulate pain sensitivity and persistence. Nat Med. 2006 Nov;12(11):1269-77. doi: 10.1038/nm1490. Epub 2006 Oct 22.
- Granot M, Ferber SG. The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45. doi: 10.1097/01.ajp.0000135236.12705.2d.
- Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C, Negrescu C, Moric M, Caicedo MS, Tuman KJ. Upregulation of prostaglandin E2 and interleukins in the central nervous system and peripheral tissue during and after surgery in humans. Anesthesiology. 2006 Mar;104(3):403-10. doi: 10.1097/00000542-200603000-00005. Erratum In: Anesthesiology. 2006 Apr;104(4):900.
- Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.
- Khan AA, Owatz CB, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. Measurement of mechanical allodynia and local anesthetic efficacy in patients with irreversible pulpitis and acute periradicular periodontitis. J Endod. 2007 Jul;33(7):796-9. doi: 10.1016/j.joen.2007.01.021. Epub 2007 Mar 26.
- Max MB, Stewart WF. The molecular epidemiology of pain: a new discipline for drug discovery. Nat Rev Drug Discov. 2008 Aug;7(8):647-58. doi: 10.1038/nrd2595. Epub 2008 Jun 27.
- Belfer I, Wu T, Kingman A, Krishnaraju RK, Goldman D, Max MB. Candidate gene studies of human pain mechanisms: methods for optimizing choice of polymorphisms and sample size. Anesthesiology. 2004 Jun;100(6):1562-72. doi: 10.1097/00000542-200406000-00032. No abstract available.
- Tegeder I, Adolph J, Schmidt H, Woolf CJ, Geisslinger G, Lotsch J. Reduced hyperalgesia in homozygous carriers of a GTP cyclohydrolase 1 haplotype. Eur J Pain. 2008 Nov;12(8):1069-77. doi: 10.1016/j.ejpain.2008.02.004. Epub 2008 Apr 18.
- Reynolds LW, Hoo RK, Brill RJ, North J, Recker DP, Verburg KM. The COX-2 specific inhibitor, valdecoxib, is an effective, opioid-sparing analgesic in patients undergoing total knee arthroplasty. J Pain Symptom Manage. 2003 Feb;25(2):133-41. doi: 10.1016/s0885-3924(02)00637-1.
- Kalff JC, Turler A, Schwarz NT, Schraut WH, Lee KK, Tweardy DJ, Billiar TR, Simmons RL, Bauer AJ. Intra-abdominal activation of a local inflammatory response within the human muscularis externa during laparotomy. Ann Surg. 2003 Mar;237(3):301-15. doi: 10.1097/01.SLA.0000055742.79045.7E.
- Gueorguieva RV, Sanacora G. Joint analysis of repeatedly observed continuous and ordinal measures of disease severity. Stat Med. 2006 Apr 30;25(8):1307-22. doi: 10.1002/sim.2270.
- Dionne RA, Berthold CW. Therapeutic uses of non-steroidal anti-inflammatory drugs in dentistry. Crit Rev Oral Biol Med. 2001;12(4):315-30. doi: 10.1177/10454411010120040301.
- Dina OA, Hucho T, Yeh J, Malik-Hall M, Reichling DB, Levine JD. Primary afferent second messenger cascades interact with specific integrin subunits in producing inflammatory hyperalgesia. Pain. 2005 May;115(1-2):191-203. doi: 10.1016/j.pain.2005.02.028.
- Chan VW, Clark AJ, Davis JC, Wolf RS, Kellstein D, Jayawardene S. The post-operative analgesic efficacy and tolerability of lumiracoxib compared with placebo and naproxen after total knee or hip arthroplasty. Acta Anaesthesiol Scand. 2005 Nov;49(10):1491-500. doi: 10.1111/j.1399-6576.2005.00782.x.
- Belfer I, Greco CM, Lokshin A, Vulakovich K, Landsittel D, Dai F, Crossett L, Chelly JE. The design and methods of genetic studies on acute and chronic postoperative pain in patients after total knee replacement. Pain Med. 2014 Sep;15(9):1590-602. doi: 10.1111/pme.12487. Epub 2014 Jul 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09050171
- N08PC10039 (Other Grant/Funding Number: US NIH/NIDCR)
- 1406-0408-CT-20481 (Other Grant/Funding Number: US NIH/NIDCR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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