The primary objective of this study is to evaluate the efficacy and safety of laparoscopic renal artery nerve blockade surgery in patients with retroperitoneal diseases complicated by hypertension. The study aims to address the following two questions: 1. Can laparoscopic renal artery perivascular nerve blockade reduce postoperative blood pressure and decrease the dependence on antihypertensive medications in patients with retroperitoneal diseases and hypertension? 2. What is the safety profile of the procedure, and does it lead to any complications? The researchers will randomly assign patients to the experimental group and the control group. The experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade, while the control group will only receive surgery related to the primary disease. This design allows for a comparison of the effects of renal artery perivascular nerve blockade on postoperative blood pressure. Participants will: 1. Patients will undergo either surgery related to the primary disease combined with renal artery perivascular nerve blockade, or surgery related to the primary disease alone. 2. For the three months following surgery, the antihypertensive medication regimen will remain unchanged from the preoperative plan. At the end of the three-month period, patients will visit the hospital for 24-hour ambulatory blood pressure monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
246
1. When only the main renal artery is present: The complete dissection of the renal artery should be performed in the distal 2/3 portion, close to the renal hilum. The connective tissue and nerve tissue within a 1 cm radius from the center of the renal artery lumen must be completely separated (using instruments such as an ultrasonic scalpel or monopolar hook, etc.). The length of the dissected renal artery should be at least 0.5 cm, forming a dissection ring. 2. When accessory renal arteries are present: In addition to the main renal artery meeting the aforementioned standards, the accessory renal arteries must also be dissected. The radius of the dissection ring should be 0.7 cm, with a length ranging from 0.3 to 0.5 cm. 3. When renal polar arteries are present: Dissection may be performed appropriately based on the surgical conditions. 4. The prerequisite is to ensure the safety of the surgery, specifically the safe resection of the primary lesion.
The surgeries related to the primary disease include laparoscopic partial nephrectomy, laparoscopic adrenalectomy, and other similar procedures.
Ruijin hospital
Shanghai, China
RECRUITINGThe blood pressure values at 3 months post-surgery.
The average systolic blood pressure (ASBP) during 24-hour ambulatory blood pressure monitoring at 3 months post-surgery.
Time frame: 3 months
The blood pressure values at other different time points.
The 24-hour ambulatory blood pressure data at 1 month, 6 months, 12 months, and 24 months post-surgery, as well as the dynamic blood pressure data at 3 months post-surgery, excluding the primary outcomes.
Time frame: 1 month, 3 months,6 months, 12 months, and 24 months
antihypertensive medications
The use of antihypertensive medications at 1 month, 3 months, 6 months, 12 months, and 24 months post-surgery.
Time frame: 1 month, 3 months,6 months, 12 months, and 24 months
Health status.
At each time point, health status will be assessed and quantified using the EuroQoL Five-Dimensions Three-Level (EQ-5D-3L) standardized scale.
Time frame: 1 month, 3 months,6 months, 12 months, and 24 months
Pain score
At each time point, Pain scores will be assessed and quantified using the Visual Analog Scale (VAS).
Time frame: 1 month, 3 months,6 months, 12 months, and 24 months
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