Regional Anesthesia MorbidityNCT03666845
Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
An observational study of Regional Anesthesia Morbidity and Local Anesthetic Drug Adverse Reaction, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Regional Anesthesia Morbidity, Local Anesthetic Drug Adverse Reaction
- What is being tested?
- Sciatic nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2019to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Sciatic nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic nerve blockProcedure or surgery
Also called Popliteal block
Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Sciatic nerve block | Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease Receives: Procedure: Sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
metabolite of ropivacaine
Measured: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Plasma concentration of pipecoloxylidide
metabolite of ropivacaine
Measured: 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")
Measured: 2, 6, 24 hours after sciatic nerve block
Local anesthetic systemic toxicity
numbness of the tongue, twitching, convulsion, dysarrhythmia, coma
Measured: 2, 6, 24 hours after sciatic nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Oct 2019
- Primary completion21 Jul 2022
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Pf., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666845
- Sponsor's protocol ID
- H-1807-153-961
- Status last verified
- Jan 2024
- First submitted
- 10 Sep 2018
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction
- ClinicalTrials.gov ID
- NCT03666845
- Acronym / sponsor ID
- H-1807-153-961
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sciatic nerve block | – | Procedure: Sciatic nerve blockPatients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sciatic nerve blockAlso: Popliteal blockSciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator. | Procedure or surgery | Sciatic nerve block |
Primary outcome
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.
4 secondary outcomes
Plasma concentration of 3-OH-ropivacaine
Time frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Plasma concentration of pipecoloxylidide
Time frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Postoperative pain score
Time frame: 2, 6, 24 hours after sciatic nerve block
Local anesthetic systemic toxicity
Time frame: 2, 6, 24 hours after sciatic nerve block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Related trials for Regional Anesthesia Morbidity
Recruiting
Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia
Regional Anesthesia, Regional Anesthesia Morbidity
Recruiting
Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries
Regional Anesthesia Morbidity, Supratentorial Brain Tumor
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Active, not recruitingObservational study
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Regional Anesthesia Morbidity, Acute Pain
Recruiting
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
Arthropathy of Hip, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, Pf. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity and Local Anesthetic Drug Adverse Reaction, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of unbound ropivacaine (time frame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.