Laparoscopic nerve blockade to lower blood pressure in patients with kidney-related diseases
Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
This study is testing if a special nerve-blocking procedure during kidney surgery can help lower blood pressure in patients with kidney-related diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06829134 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of laparoscopic renal artery nerve blockade in patients suffering from hypertension due to retroperitoneal diseases. Participants will be randomly assigned to either an experimental group, which will receive the nerve blockade in addition to surgery for their primary condition, or a control group that will only undergo the primary surgery. The study aims to determine if the nerve blockade can reduce postoperative blood pressure and reliance on antihypertensive medications, while also assessing any potential complications from the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a clear diagnosis of hypertension and scheduled for laparoscopic surgery related to conditions like adrenal tumors or renal malignancies.
Not a fit: Patients with renal artery diameters less than 4 mm or those with severe hypertension not meeting the study's criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce blood pressure and the need for antihypertensive medications in patients with retroperitoneal diseases.
How similar studies have performed: While similar approaches have been explored, this specific intervention is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.