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

Completed

• Conditions: Local Anesthetic Drug Adverse Reaction; Regional Anesthesia Morbidity
• Interventions: Procedure: Sciatic nerve block

• Registration Number: NCT03666845
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Study Start: 2019-10-01
• Primary Completion: 2022-07-21
• Study Completion: 2023-12-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Plasma concentration of unbound ropivacaine	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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of