Actively Recruiting
Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
Led by Ruijin Hospital · Updated on 2025-02-17
246
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of laparoscopic renal artery perivascular nerve blockade surgery for patients who have retroperitoneal diseases and hypertension. The study aims to find out if this nerve blockade can reduce blood pressure after surgery and lessen the need for blood pressure medications. It also aims to assess the safety of the procedure and whether it causes any complications. Participants will be randomly assigned to one of two groups. One group will receive surgery related to their primary disease along with the nerve blockade procedure, while the other group will only have the surgery related to their primary disease, such as laparoscopic partial nephrectomy or adrenalectomy. The nerve blockade involves carefully dissecting the renal artery to separate nerve tissue within specific measurements, ensuring surgical safety. During the study, patients will keep their antihypertensive medication unchanged for three months following surgery. After this period, they will have a 24-hour ambulatory blood pressure monitoring visit at the hospital. Researchers will measure blood pressure at three months post-surgery as the primary outcome. Secondary outcomes include blood pressure at other time points, medication use, health status, and pain scores, assessed up to two years after surgery.
CONDITIONS
Brief Title
Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Renal artery diameter at least 4 mm and length at least 20 mm
- Age between 18 and 75 years, any gender
- Scheduled for laparoscopic surgery for conditions like adrenal tumor, early-stage kidney cancer, or kidney cyst meeting surgical guidelines
- Diagnosed with hypertension by blood pressure measurements or current antihypertensive medication use for at least 4 weeks
- Kidney function with estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73 m² or higher
- Willing and able to follow study procedures, give informed consent, and participate in follow-up visits
You will not qualify if you...
- Significant narrowing or abnormalities of the renal artery, or previous renal artery balloon angioplasty or stent
- Recent serious heart or brain events within past 6 months, including heart attack, unstable angina, or stroke
- History of similar nerve ablation surgeries
- Presence of other severe organic diseases
- Currently participating in other clinical studies
- Judged unsuitable for participation by the investigator based on medical expertise
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo surgery related to their primary disease. The experimental group also receives laparoscopic renal artery perivascular nerve blockade during surgery. Immediate recovery and care follow the surgery.
1 surgical visit and hospital stay
Duration - Up to 24 months
Participants are monitored for blood pressure, medication use, health status, and pain at multiple time points after surgery.
Follow-up visits at 1 month, 3 months, 6 months, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
Ruijin hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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