An interventional study of laparoscopic renal artery perivascular nerve blockade and surgery related to the primary disease in Hypertension and Retroperitoneal Disease, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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:
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:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 246 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
The experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade.
Procedure: laparoscopic renal artery perivascular nerve blockade · Procedure: surgery related to the primary disease
The control group will only receive surgery related to the primary disease. Such as laparoscopic partial nephrectomy, laparoscopic adrenalectomy etc.
Procedure: surgery related to the primary disease
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.
The 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
Plan to share: No
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