A Phase 4 interventional study of Ropivacaine and Lidocaine in End Stage Renal Disease (ESRD), Arteriovenous Fistula Patency and Chronic Kidney Disease 5D, sponsored by The First People's Hospital of Lianyungang. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by The First People's Hospital of Lianyungang · Phase 4, Interventional, and Treatment
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:
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.
Blinding \& Drug Preparation: To maintain blinding, all anesthetic solutions were prepared by the hospital pharmacy under aseptic conditions. Both solutions were clear, colorless, and dispensed in identical 20mL syringes labeled only with the study ID and patient randomization number.
Standardized Infiltration Protocol: A fixed sequence was used: subcutaneous infiltration along the planned 3-4 cm incision line, followed by targeted perivascular infiltration around the exposed radial artery and cephalic vein using a 25-gauge needle.
Standardized Surgical Protocol (Per Study Procedures): All surgeries were performed by the same high-volume surgeon. With the patient in the supine position and the operative limb abducted, a 3-4 cm skin incision was made between the artery and vein. The cephalic vein and radial artery were carefully dissected. The distal cephalic vein was ligated and divided. While an assistant compressed the cubital fossa, heparinized saline (5000 IU in 500 mL saline) was injected through the proximal vein to fully dilate the forearm cephalic vein. Vascular clamps were then applied to occlude the radial artery. Parallel longitudinal incisions (0.8-1 cm) were made in both vessels. The anastomosis was completed using continuous everting sutures on both the anterior and posterior walls. After clamp release and confirmation of fistula patency, the incision was closed in layers.
Intraoperative Adjuncts: All patients received the aforementioned irrigation with heparinized saline for venous dilation.
Protocol-Specified Additional Monitoring \& Quality Assurance:
Extended Monitoring: Beyond pre-specified outcomes, the protocol mandated daily wound assessments for the first postoperative week and monitoring for signs of local anesthetic systemic toxicity (LAST) within 24 hours.
Data Quality Control: To minimize bias, a single, uniformly trained research assistant, blinded to group allocation, was responsible for collecting all intraoperative and postoperative data, including pain scores. Source data verification was performed for all primary outcome measures.
Study Progress Context (as of November 2025): Patient enrollment (n=40) and all surgical procedures were completed between April 2019 and February 2020. The study is currently in the long-term follow-up phase, tracking the 5-year primary unassisted patency endpoint. Blinding has been maintained throughout follow-up. Final data collection for the 5-year endpoint is anticipated by June 2026.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's enrollment of 40 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The First People's Hospital of Lianyungang is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative ultrasound findings of:
Patients receiving 0.375% ropivacaine (75 mg in 20 mL) for local infiltration anesthesia
Drug: Ropivacaine
Patients receiving 0.67% lidocaine (100 mg in 15 mL) for local infiltration anesthesia
Drug: Lidocaine
0.375% ropivacaine solution (75 mg total dose in 20 mL volume) administered as local infiltration anesthesia for arteriovenous fistula surgery
0.67% lidocaine solution (100 mg total dose in 15 mL volume) administered as local infiltration anesthesia
Intraoperative Pain Scores
Pain intensity assessed using 10-point Visual Analog Scale (0 = no pain, 10 = worst pain imaginable)
Time frame: During surgery (at the end of the procedure)
Operative Time
Duration from skin incision to wound closure (minutes)
Time frame: During surgery
Need for Supplemental Anesthesia
Requirement for additional anesthetic doses due to patient-reported intolerable pain after initial infiltration
Time frame: During surgery
Postoperative Pain Scores
Pain intensity assessed using 10-point Visual Analog Scale
Time frame: 24 hours postoperatively
Incidence of Postoperative Vasospasm
Development of arteriovenous fistula tremor reduction or absence within 48 hours postoperatively
Time frame: 48 hours postoperatively
Surgical Success Rate
Successful creation of functional arteriovenous fistula
Time frame: Immediately after surgery
Postoperative Complications
Incidence of hematoma or hemorrhage within 24 hours after surgery
Time frame: 24 hours postoperatively
Fistula Maturation at 8 Weeks
Clinical maturation defined as easily palpable vein with straight segment \>10 cm, adequate diameter, and well-palpable thrill; OR ultrasonographic maturation defined as outflow vein diameter \>6 mm, depth \<6 mm, and blood flow \>500 mL/min
Time frame: 8 weeks postoperatively
Primary Unassisted Patency at 1 Year
Interval from access creation until first access occlusion or any intervention to maintain/restore patency
Time frame: 1 year postoperatively
Primary Unassisted Patency at 5 Years
Interval from access creation until first access occlusion or any intervention to maintain/restore patency
Time frame: 5 years postoperatively
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data that underlie the results reported in publications will be shared, including demographic data, baseline characteristics, primary and secondary outcome measures, and safety data.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First People's Hospital of Lianyungang