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Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666845
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.


Condition or disease Intervention/treatment
Regional Anesthesia Morbidity Local Anesthetic Drug Adverse Reaction Procedure: Sciatic nerve block

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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")

  4. 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
Arterial blood sampling will be taken at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jin-Tae Kim, Pf. +82-2-2072-3592 jintae73@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin-Tae Kim, Pf.    +82-2-2072-3295    jintae73@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, Pf. Seoul National University Hospital

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03666845    
Other Study ID Numbers: H-1807-153-961
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents