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Active, not recruiting Phase 4

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

NCT07259772 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2019-04-10
Last updated
2025-12-09

Condition(s) studied

End Stage Renal Disease (ESRD)Arteriovenous Fistula PatencyChronic Kidney Disease 5D

Investigational drug(s) / intervention(s)

Ropivacaine →Lidocaine →

Ropivacaine: 0.375% ropivacaine solution (75 mg total dose in 20 mL volume) administered as local infiltration anesthesia for arteriovenous fistula surgery

Lidocaine: 0.67% lidocaine solution (100 mg total dose in 15 mL volume) administered as local infiltration anesthesia

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients (aged ≥18 years) scheduled for primary radiocephalic arteriovenous fistula creation * Diagnosed with end-stage renal disease requiring hemodialysis * Willing and able to provide written informed consent Exclusion Criteria: 1. History of arteriovenous fistula on the ipsilateral limb 2. Impaired communication abilities or inability to complete questionnaires due to language barriers, or missing essential data 3. Preoperative ultrasound findings of: * Radial or brachial artery diameter \<1.8 mm * Cephalic vein diameter \<2 mm at the wrist or \<3 mm at the elbow (without tourniquet application) 4. Known allergy to local anesthetics (ropivacaine or lidocaine) 5. Coagulopathy or bleeding disorders 6. Local infection at the planned anesthesia or surgical site 7. Severe peripheral neuropathy or neurological disorders affecting upper limb function 8. Significant thrombosis or severe stenosis in the proximal major veins or central veins of the limb 9. Pregnancy or breastfeeding 10. Participation in another clinical trial within 30 days

Primary outcome measure(s)

  • Intraoperative Pain Scores — During surgery (at the end of the procedure)
    Pain intensity assessed using 10-point Visual Analog Scale (0 = no pain, 10 = worst pain imaginable)
  • Operative Time — During surgery
    Duration from skin incision to wound closure (minutes)
  • Need for Supplemental Anesthesia — During surgery
    Requirement for additional anesthetic doses due to patient-reported intolerable pain after initial infiltration
  • Postoperative Pain Scores — 24 hours postoperatively
    Pain intensity assessed using 10-point Visual Analog Scale
  • Incidence of Postoperative Vasospasm — 48 hours postoperatively
    Development of arteriovenous fistula tremor reduction or absence within 48 hours postoperatively

Trial sites (1)

FacilityCityRegionStatus
Lianyungang First People's Hospital Lianyungang Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07259772 on ClinicalTrials.gov ↗ ← All trials in China