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

NCT07259772 | Active Not Recruiting Phase 4

• 1 other identifier: LW-20241021002-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Ropivacaine; Local Anesthesia; Infiltration Anesthesia; Arteriovenous Fistula Surgery; Hemodialysis Access; Randomized Controlled Trial; Vascular Access; Lidocaine; Pain Control

Outcome Measures

Primary Outcomes (5)

• Intraoperative Pain Scores

  Pain intensity assessed using 10-point Visual Analog Scale (0 = no pain, 10 = worst pain imaginable)

  During surgery (at the end of the procedure)

• Operative Time

  Duration from skin incision to wound closure (minutes)

  During surgery

• Need for Supplemental Anesthesia

  Requirement for additional anesthetic doses due to patient-reported intolerable pain after initial infiltration

  During surgery

• Postoperative Pain Scores

  Pain intensity assessed using 10-point Visual Analog Scale

  24 hours postoperatively

• Incidence of Postoperative Vasospasm

  Development of arteriovenous fistula tremor reduction or absence within 48 hours postoperatively

  48 hours postoperatively

Secondary Outcomes (5)

• Surgical Success Rate

  Immediately after surgery

• Postoperative Complications

  24 hours postoperatively

• Fistula Maturation at 8 Weeks

  8 weeks postoperatively

• Primary Unassisted Patency at 1 Year

  1 year postoperatively

• Primary Unassisted Patency at 5 Years

  5 years postoperatively

Study Arms (2)

Ropivacaine Group

EXPERIMENTAL

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

Drug: Ropivacaine

Lidocaine Group

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

Ropivacaine DRUG

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

Ropivacaine Group

Lidocaine DRUG

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

Lidocaine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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)
• 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
• Pregnancy or breastfeeding
• Participation in another clinical trial within 30 days

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Study Sites (1)

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

Related Publications (3)

• Budharapu A, Sinha R, Uppada UK, Subramanya Kumar AV. Ropivacaine: a new local anaesthetic agent in maxillofacial surgery. Br J Oral Maxillofac Surg. 2015 May;53(5):451-4. doi: 10.1016/j.bjoms.2015.02.021. Epub 2015 Mar 24.

  PMID: 25818492 BACKGROUND

• Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.

  PMID: 32778223 BACKGROUND

• Schmidli J, Widmer MK, Basile C, de Donato G, Gallieni M, Gibbons CP, Haage P, Hamilton G, Hedin U, Kamper L, Lazarides MK, Lindsey B, Mestres G, Pegoraro M, Roy J, Setacci C, Shemesh D, Tordoir JHM, van Loon M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Lindholt J, Naylor R, Vega de Ceniga M, Vermassen F, Verzini F, Esvs Guidelines Reviewers, Mohaupt M, Ricco JB, Roca-Tey R. Editor's Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757-818. doi: 10.1016/j.ejvs.2018.02.001. Epub 2018 May 2. No abstract available.

  PMID: 29730128 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Agnosia

Interventions

Ropivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Liyuan Zhang

  Lianyungang First People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where both patients and surgeons are blinded to the intervention. The anesthetic preparations are performed by resident physicians, circulating nurses, and scrub nurses who are not involved in outcomes assessment. The allocation assignments are concealed in sequentially numbered, opaque, sealed envelopes that are opened immediately prior to anesthesia administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm parallel group randomized controlled trial comparing ropivacaine versus lidocaine for local infiltration anesthesia in arteriovenous fistula surgery. Participants are randomly assigned to one of two treatment groups and remain in that group throughout the study period.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: April 10, 2019
• Primary Completion: March 31, 2021
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will become available 6 months after publication of the primary results and will be accessible for 5 years.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to the corresponding author. Requestors will need to sign a data access agreement.

Locations

CN (1)