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

Regional Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666845
• Other study ID #: H-1807-153-961
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 28, 2023

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 28, 2023
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Local Anesthetic Drug Adverse Reaction
• Regional Anesthesia Morbidity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Plasma concentration of pipecoloxylidide	metabolite of ropivacaine	2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Secondary	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
Secondary	Local anesthetic systemic toxicity	numbness of the tongue, twitching, convulsion, dysarrhythmia, coma	2, 6, 24 hours after sciatic nerve block