Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension

Overview

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.

Interventions

• Procedure laparoscopic renal artery perivascular nerve blockade
  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 ar
• Procedure surgery related to the primary disease
  The surgeries related to the primary disease include laparoscopic partial nephrectomy, laparoscopic adrenalectomy, and other similar procedures.

Primary outcome measures

• The blood pressure values at 3 months post-surgery. [Time frame: 3 months]

Secondary outcome measures (4)

• The blood pressure values at other different time points. [Time frame: 1 month, 3 months，6 months, 12 months, and 24 months]
• antihypertensive medications [Time frame: 1 month, 3 months，6 months, 12 months, and 24 months]
• Health status. [Time frame: 1 month, 3 months，6 months, 12 months, and 24 months]
• Pain score [Time frame: 1 month, 3 months，6 months, 12 months, and 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin hospital — Shanghai

Identifiers

NCT: NCT06829134 · 2024-489

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗