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

Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction

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 Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity; Local Anesthetic Drug Adverse Reaction
• Intervention / Treatment: Procedure: Sciatic nerve block

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Popliteal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of unbound ropivacaine	whether the unbound plasma concentration of ropivacaine was maintained under 0.56 mcg/ml that was determined as toxic level in a previous study.	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of 3-OH-ropivacaine	metabolite of ropivacaine	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Plasma concentration of pipecoloxylidide	metabolite of ropivacaine	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Postoperative pain score	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")	2, 6, 24 hours after sciatic nerve block
Local anesthetic systemic toxicity	numbness of the tongue, twitching, convulsion, dysarrhythmia, coma	2, 6, 24 hours after sciatic nerve block

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, Pf., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: H-1807-153-961

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No