Chronic Pain Clinical Trial
Official title:
Perioperative Dexamethasone to Promote Systemic Pro-Resolution Phenotype for Prevention of Acute and Chronic Pain Post-Total Knee Arthroplasty.
Verified date | January 2018 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is three fold. First to determine the ideal dose of dexamethasone intraoperatively that will reduce acute pain and opioid consumption. Second determine if dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty and finally determine if a pro-inflammatory environment makes patients susceptible to chronic pain after surgery and can dexamethasone alter this environment. Patients undergoing total knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg dexamethasone) and assessments will be made of acute and chronic pain and quality of life measures. Blood samples will be drawn to assess Interleukin levels and for Macrophage sorting. For the primary efficacy endpoint of reduction of opioid consumption over 24 hours after surgery the dexamethasone regimen group will be compared to standard of care group using t-test. For comparisons of the secondary efficacy endpoints, t-test, Chi-square test and Fisher's Exact test will be used. Risks of this study include the risks of venipuncture and intravenous dexamethasone administration.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Patients scheduled to undergo unilateral total knee arthroplasty. - American Society of Anesthesiology (ASA) Physical Class 1-3. - BMI <40 kg/m2 Exclusion Criteria: - Revision surgery. - Bilateral total knee arthroplasty. - Unicompartmental knee arthroplasty. - Patients with a contraindication to regional anesthesia. This includes abnormal clotting, skin infection in groin or near the back, the presence of neurological disorders or anatomical abnormalities of the vertebral column. - Contraindications or known drug interactions with dexamethasone. - Use of any of the following medications within the times specified before surgery: - Long-acting opioid medication within 3 days. - Any opioid medication within 24 hours. - Body weight less than 50 kilograms (~110 pounds). - Planned administration of another investigational product or procedure during the subject's participation in this study. - Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. - Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. - Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course. - Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function (Ejection fraction under 35%), epilepsy, myasthenia gravis), severe renal impairment (creatinine > 1.8), comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy. |
Country | Name | City | State |
---|---|---|---|
United States | DUMC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Macrophage Proliferation | Macrophage totals and differentiation will be assessed within patients and between groups. | Samples will be taken immediately pre incision and will be repeated at 33-39hours | |
Other | Change in Interleukin 6 and 10 Levels | Interleukin levels and the ratio will assess pro and anti inflammatory processes in the patients | Sample immediately prior to incision and at 10-14, 22-26 and 33-39hours after surgery. | |
Primary | Change in Visual Analogue Pain Score | Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever. | 6, 12, 18, 24, 36 hours after surgery | |
Primary | Change in Opioid Consumption | mg of morphine equivalents | 6, 12, 18, 24, 36 hours after surgery | |
Secondary | Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index | The Western Ontario and McMaster Universities Osteoarthritis Index measures 17 items for functional limitation (score range 0-68). Higher score = higher difficulty with the task. | 30 days, 3 and 6 months following surgery | |
Secondary | Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire | Brief pain inventory questionnaire will be administered generating a score (0-40). Higher scores reflect higher perceived pain. | Baseline at enrollment, 3 months and 6 months after surgery | |
Secondary | Change in Functional Status as Measured by Brief Pain Inventory Questionnaire | Brief pain inventory questionnaire will be administered generating a score (0-70). Higher scores reflect higher perceived pain interference. | Baseline at Enrollment, 3 and 6 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|