Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03666845|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 7, 2019
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.
|Condition or disease||Intervention/treatment|
|Regional Anesthesia Morbidity Local Anesthetic Drug Adverse Reaction||Procedure: Sciatic nerve block|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Sciatic nerve block
Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease
Procedure: Sciatic nerve block
Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.
Other Name: Popliteal block
- 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.
- Plasma concentration of 3-OH-ropivacaine [ Time Frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block ]metabolite of ropivacaine
- Plasma concentration of pipecoloxylidide [ Time Frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block ]metabolite of ropivacaine
- Postoperative pain score [ Time Frame: 2, 6, 24 hours after sciatic nerve block ]11-point numeric rating scale ranging from '0' representing one extreme (e.g. "extremely dissatisfied") to '10' representing the other extreme (e.g. "extremely satisfied")
- Local anesthetic systemic toxicity [ Time Frame: 2, 6, 24 hours after sciatic nerve block ]numbness of the tongue, twitching, convulsion, dysarrhythmia, coma
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666845
|Contact: Jin-Tae Kim, Pf.||+firstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jin-Tae Kim, Pf. +82-2-2072-3295 email@example.com|
|Principal Investigator:||Jin-Tae Kim, Pf.||Seoul National University Hospital|