End Stage Renal Disease (ESRD)Phase 4NCT07259772
Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery
A Phase 4 study testing Ropivacaine and Lidocaine in people with End Stage Renal Disease (ESRD) and Arteriovenous Fistula Patency, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Arteriovenous Fistula Patency, Chronic Kidney Disease 5D
- What is being tested?
- Ropivacaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2019to Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed 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.
- Being tested
- Ropivacaine, Lidocaine
- Keywords
- Ropivacaine, Local Anesthesia, Infiltration Anesthesia, Arteriovenous Fistula Surgery, Hemodialysis Access, Randomized Controlled Trial, Vascular Access, Lidocaine, Pain Control
- Medical subject headings
- Kidney Failure, Chronic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.375% ropivacaine solution (75 mg total dose in 20 mL volume) administered as local infiltration anesthesia for arteriovenous fistula surgery
LidocaineDrug
0.67% lidocaine solution (100 mg total dose in 15 mL volume) administered as local infiltration anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Group | Experimental | Patients receiving 0.375% ropivacaine (75 mg in 20 mL) for local infiltration anesthesia Receives: Drug: Ropivacaine |
| Lidocaine Group | Active comparator | Patients receiving 0.67% lidocaine (100 mg in 15 mL) for local infiltration anesthesia Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Pain Scores
Pain intensity assessed using 10-point Visual Analog Scale (0 = no pain, 10 = worst pain imaginable)
Measured: During surgery (at the end of the procedure)
Operative Time
Duration from skin incision to wound closure (minutes)
Measured: During surgery
Need for Supplemental Anesthesia
Requirement for additional anesthetic doses due to patient-reported intolerable pain after initial infiltration
Measured: During surgery
Postoperative Pain Scores
Pain intensity assessed using 10-point Visual Analog Scale
Measured: 24 hours postoperatively
Incidence of Postoperative Vasospasm
Development of arteriovenous fistula tremor reduction or absence within 48 hours postoperatively
Measured: 48 hours postoperatively
Secondary outcomes (5)
Surgical Success Rate
Successful creation of functional arteriovenous fistula
Measured: Immediately after surgery
Postoperative Complications
Incidence of hematoma or hemorrhage within 24 hours after surgery
Measured: 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
Measured: 8 weeks postoperatively
Primary Unassisted Patency at 1 Year
Interval from access creation until first access occlusion or any intervention to maintain/restore patency
Measured: 1 year postoperatively
Primary Unassisted Patency at 5 Years
Interval from access creation until first access occlusion or any intervention to maintain/restore patency
Measured: 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Apr 2019
- Primary completion31 Mar 2021
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyuan Zhang, Principal investigator, Lianyungang First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259772
- Sponsor's protocol ID
- LW-20241021002-01
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 25818492Lok 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.
PubMed 32778223Schmidli 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.
PubMed 29730128