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Completed

NCT Number: NCT03666845

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

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.

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Key information

Conditions

Regional Anesthesia Morbidity Local Anesthetic Drug Adverse Reaction

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sciatic Nerve Block

Procedure

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

Other names: Popliteal block

Primary outcomes

  1. Plasma concentration of unbound ropivacaine

    Time frame: 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 outcomes

  1. Plasma concentration of 3-OH-ropivacaine

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

    metabolite of ropivacaine

  2. Plasma concentration of pipecoloxylidide

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

    metabolite of ropivacaine

  3. Postoperative pain score

    Time frame: 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")

  4. Local anesthetic systemic toxicity

    Time frame: 2, 6, 24 hours after sciatic nerve block

    numbness of the tongue, twitching, convulsion, dysarrhythmia, coma

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 12, 2018
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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