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

NCT03666845 | Completed

• 1 other identifier: H-1807-153-961
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity; Local Anesthetic Drug Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Plasma concentration of 3-OH-ropivacaine

  2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block

• Plasma concentration of pipecoloxylidide

  2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block

• Postoperative pain score

  2, 6, 24 hours after sciatic nerve block

• Local anesthetic systemic toxicity

  2, 6, 24 hours after sciatic nerve block

Study Arms (1)

Sciatic nerve block

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

Procedure: Sciatic nerve block

Interventions

Sciatic nerve block PROCEDURE

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

Also known as: Popliteal block

Sciatic nerve block

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

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.

Study Officials

• Jin-Tae Kim, Pf.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: October 1, 2019
• Primary Completion: July 21, 2022
• Study Completion: December 28, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

KR (1)