Total Knee Arthroplasty Clinical Trial
Official title:
The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks
Verified date | June 2014 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.
Status | Terminated |
Enrollment | 43 |
Est. completion date | May 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 18-80 yrs, male or female subjects. - Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control. - American Society of Anesthesiology Class 1,2,3,or 4. - Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked. - Weight > or equal to 60kg. Exclusion Criteria: - Any allergies or hypersensitivity to ropivacaine or dexamethasone. - Subject is on chronic steroids preoperatively for any reason. - History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy). - History of documented or stated nerve damage or neuropathy to the surgical lower extremity. - Contraindication to placement of sciatic nerve block. - Sciatic block placement failure. - Subject mistakenly receives steroids intraoperatively. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Sciatic Nerve Block | Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores | from the time the block was placed up to 24 hours | No |
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