Clinical trial NCT06829134: Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
Official title: Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Retroperitoneal Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Renal artery diameter ≥ 4 mm, length ≥ 20 mm.
* Age between 18 and 75 years, male or female.
* Scheduled to undergo laparoscopic surgery: The patient has a clear diagnosis of adrenal tumor, early-stage renal malignancy, renal cyst, etc., and meets the surgical indications recommended by guidelines or relative surgical indications but has a strong willingness for surgery. The patient requires surgery (such as laparoscopic partial adrenalectomy, laparoscopic unilateral adrenalectomy, laparoscopic partial nephrectomy, laparoscopic renal cyst decapitation, etc.) and meets the surgical conditions.
* A clear diagnosis of hypertension: Either the patient has never used antihypertensive medications, with in-office blood pressure ≥ 140/90 mmHg and \< 180/110 mmHg, or 24-hour daytime ambulatory blood pressure ≥ 135/85 mmHg and \< 170/105 mmHg. Alternatively, the patient has been diagnosed with hypertension and has been taking antihypertensive medications for at least 4 weeks.
* Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73 m².
* The patient is willing and able to comply with the study protocol, provide written informed consent, and agrees to participate in follow-up assessments.

Exclusion Criteria:

* Renal artery abnormalities: Hemodynamic or anatomical stenosis (≥50%) of one renal artery; post-renal artery balloon angioplasty or stent placement;
* Cardiovascular risk factors: Including myocardial infarction, unstable angina, or cerebrovascular events within the past 6 months; extensive atherosclerosis with intravascular thrombosis or unstable plaques; and significant hemodynamic changes due to heart valve disease;
* History of similar surgeries: Such as previous renal sympathetic nerve ablation via catheter;
* Other severe organic diseases;
* Participation in other clinical studies;
* Investigator's judgment: The investigator determines that, based on medical expertise, the patient is unsuitable for participation in the study.

Primary outcomes:
measure: The blood pressure values at 3 months post-surgery.
timeFrame: 3 months
Secondary outcomes:
measure: The blood pressure values at other different time points.
timeFrame: 1 month, 3 months，6 months, 12 months, and 24 months
measure: antihypertensive medications
timeFrame: 1 month, 3 months，6 months, 12 months, and 24 months
measure: Health status.
timeFrame: 1 month, 3 months，6 months, 12 months, and 24 months
measure: Pain score
timeFrame: 1 month, 3 months，6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
Study officials:
References: