Active — Not RecruitingPhase 4

Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery

China40 participantsStarted 2019-04-10

Plain-language summary

This study compares two local anesthetics, ropivacaine and lidocaine, for patients undergoing arteriovenous fistula surgery. Arteriovenous fistula is the preferred vascular access for end-stage kidney disease patients needing hemodialysis. In this clinical trial, patients are randomly assigned to receive either ropivacaine or lidocaine for local anesthesia during the surgery. Researchers are evaluating which medication provides better pain control and improves surgical outcomes. The study is examining: * Pain levels during and after surgery * Surgery duration * Need for additional pain medication * Surgical complications * Fistula development over time * Long-term fistula function at 1 year and 5 years This is a double-blind study, meaning neither patients nor surgeons know which medication is being used. The study is currently ongoing with active patient follow-up and is expected to be completed in June 2026. Patients are being followed for up to 5 years to monitor their long-term progress. This research may help doctors choose the best local anesthetic for arteriovenous fistula surgery, potentially leading to better pain control and improved long-term outcomes for kidney disease patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. History of arteriovenous fistula on the ipsilateral limb
. Impaired communication abilities or inability to complete questionnaires due to language barriers, or missing essential data
. Preoperative ultrasound findings of:
. Known allergy to local anesthetics (ropivacaine or lidocaine)
. Coagulopathy or bleeding disorders
. Local infection at the planned anesthesia or surgical site
. Severe peripheral neuropathy or neurological disorders affecting upper limb function
. Significant thrombosis or severe stenosis in the proximal major veins or central veins of the limb

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative Pain Scores

Timeframe: During surgery (at the end of the procedure)

Operative Time

Timeframe: During surgery

Need for Supplemental Anesthesia

Timeframe: During surgery

Postoperative Pain Scores

Timeframe: 24 hours postoperatively

Incidence of Postoperative Vasospasm

Timeframe: 48 hours postoperatively

Trial details

NCT IDNCT07259772

SponsorThe First People's Hospital of Lianyungang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More End Stage Renal Disease (ESRD) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. History of arteriovenous fistula on the ipsilateral limb
. Impaired communication abilities or inability to complete questionnaires due to language barriers, or missing essential data
. Preoperative ultrasound findings of:
. Known allergy to local anesthetics (ropivacaine or lidocaine)
. Coagulopathy or bleeding disorders
. Local infection at the planned anesthesia or surgical site
. Severe peripheral neuropathy or neurological disorders affecting upper limb function
. Significant thrombosis or severe stenosis in the proximal major veins or central veins of the limb

What they're measuring

Intraoperative Pain Scores

Timeframe: During surgery (at the end of the procedure)

Operative Time

Timeframe: During surgery

Need for Supplemental Anesthesia

Timeframe: During surgery

Postoperative Pain Scores

Timeframe: 24 hours postoperatively

Incidence of Postoperative Vasospasm

Timeframe: 48 hours postoperatively