NCT03666845CompletedNot Applicable
Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction
Seoul National University Hospital1 site in 1 country5 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Plasma concentration of unbound ropivacaine
Study Overview
Brief Summary
This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in patients with chronic kidney disease after sciatic nerve block.
Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for foot and ankle surgery
- •Patients with chronic kidney disease (glomerular filtration rate < 60 ml/min/1.73m2) (changed from 30 ml/min/1.73m2 to facilitate patient recruitment)
- •Patients who are thought to be clinically helpful to receive sciatic nerve block rather than general anesthesia because of comorbidities such as cardiopulmonary dysfunction and cerebral dysfunction
Exclusion Criteria
- •Patients who need to renal replacement therapy, such as hemodialysis
- •Patients with liver disease (aspartate transaminase OR alanine transaminase > 80 IU/L)
- •Patients with allergic disease
- •Patients with previous history of drug allery
- •Patients with chronic pain persisting 3 months
Outcomes
Primary Outcomes
Plasma concentration of unbound ropivacaine
Time Frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
whether the unbound plasma concentration of ropivacaine was maintained under 0.56 mcg/ml that was determined as toxic level in a previous study.
Secondary Outcomes
- Plasma concentration of 3-OH-ropivacaine(2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block)
- Plasma concentration of pipecoloxylidide(2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block)
- Local anesthetic systemic toxicity(2, 6, 24 hours after sciatic nerve block)
- Postoperative pain score(2, 6, 24 hours after sciatic nerve block)
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
Study Sites (1)
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