Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative Pain Scores
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ropivacaine Group
Patients receiving 0.375% ropivacaine (75 mg in 20 mL) for local infiltration anesthesia
干预措施: Ropivacaine (Drug)
Lidocaine Group
Patients receiving 0.67% lidocaine (100 mg in 15 mL) for local infiltration anesthesia
干预措施: Lidocaine (Drug)
结局指标
主要结局
Intraoperative Pain Scores
时间窗: 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
时间窗: During surgery
Duration from skin incision to wound closure (minutes)
Need for Supplemental Anesthesia
时间窗: During surgery
Requirement for additional anesthetic doses due to patient-reported intolerable pain after initial infiltration
Postoperative Pain Scores
时间窗: 24 hours postoperatively
Pain intensity assessed using 10-point Visual Analog Scale
Incidence of Postoperative Vasospasm
时间窗: 48 hours postoperatively
Development of arteriovenous fistula tremor reduction or absence within 48 hours postoperatively
次要结局
- 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)