Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty., Sciatic nerve Blocks., Dexamethasone.
Brief summary
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.
Interventions
DRUGRopivacaine
20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
DRUGDexamethasone
8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
DRUGNormal Saline
2ml of normal saline given once intravenously.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sciatic Nerve Block | from the time the block was placed up to 24 hours | 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 |
Countries
United States
Participant flow
Recruitment details
The recruitment process began on 10/4/2007. The last subject to be recruited was on 02/23/2009. Subjects were consented at their Pre-anesthesia appointment or in the Observation Unit prior to their surgery.Some subjects were pre-consented by a resident on the phone prior to their surgery date.
Pre-assignment details
We had 4 subjects withdraw because of screen failure, rescheduled surgery and physcian withdrawal.
Participants by arm
| Arm | Count |
|---|---|
| Group A This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline. | 14 |
| Group B Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline. | 14 |
| Group C Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone. | 15 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Group B | Group C | Group A | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 9 Participants | 7 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 7 Participants | 18 Participants |
| Age, Continuous | 67.692 years STANDARD_DEVIATION 7.357 | 67.714 years STANDARD_DEVIATION 7.859 | 63.154 years STANDARD_DEVIATION 10.597 | 65.525 years STANDARD_DEVIATION 9.14 |
| Region of Enrollment United States | 14 participants | 15 participants | 14 participants | 43 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: from the time the block was placed up to 24 hours
Population: PI left the institution and no analysis completed due to questionable data integrity