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

The First People's Hospital of Lianyungang

Status and phase: Active, not recruiting; Phase 4

Conditions: Arteriovenous Fistula Patency; Chronic Kidney Disease 5D; End Stage Renal Disease (ESRD)

Treatments: Drug: Ropivacaine; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07259772

LW-20241021002-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Ropivacaine Group

Experimental group

Description:

Patients receiving 0.375% ropivacaine (75 mg in 20 mL) for local infiltration anesthesia

Treatment:

Drug: Ropivacaine

Lidocaine Group

Active Comparator group

Description:

Patients receiving 0.67% lidocaine (100 mg in 15 mL) for local infiltration anesthesia

Treatment:

Drug: Lidocaine