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

NCT ID: NCT03666845

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Regional Anesthesia Morbidity Local Anesthetic Drug Adverse Reaction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sciatic nerve block

Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease

Sciatic nerve block

Intervention Type PROCEDURE

Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.

Interventions

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Sciatic nerve block

Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.

Intervention Type PROCEDURE

Other Intervention Names

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Popliteal block

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, Pf.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1807-153-961

Identifier Type: -

Identifier Source: org_study_id

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