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临床试验/NCT06566521
NCT06566521招募中不适用

Effect of Thoracic Paravertebral Block on Analgesia and the Quality of Recovery Following Daytime Laparoscopic Partial Adrenalectomy

Shanxi Bethune Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Quality of Recovery

研究概览

简要总结

Day surgery refers to the entire diagnostic and therapeutic process completed within 24-48 h, including patient admission, surgery, and discharge. Research by Shariq et al suggested that daytime laparoscopic adrenalectomy was a safe and effective alternative to traditional inpatient treatment. Li et al demonstrated that daytime surgery for laparoscopic partial adrenalectomy could reduce hospital stays, lower medical costs, and optimize healthcare resource utilization.

The day surgery has put forward higher requirements for the management of perioperative anesthesia, in which the postoperative multimodal analgesia is particularly important.Thoracic paravertebral block (TPVB) is a regional block technique in which local anaesthetics can be injected into paravertebral space to block the ipsilateral sympathetic and somatosensory nerves. TPVB single point injection can achieve sensory block of 3-6 spinal ganglia on one side, with minimal impact on respiratory, gastrointestinal and bladder function. Especially, TPVB does not affect motor nerve, which enable patients to perform painless functional exercise shortly after surgery, promote rapid recovery, and enhance satisfaction and comfort.

A large number of previous studies have shown that TPVB had become increasingly popular for postoperative analgesia after thoracic or breast surgery. However, to our knowledge, few studies to date have investigated the application of TPVB in daytime adrenal surgery. Therefore, we conducted this randomized clinical trial to examine the effect of TPVB on postoperative analgesia and the quality of recovery in patients following daytime laparoscopic partial adrenalectomy.

详细描述

  1. Study purpose

To investigate the impact of thoracic paravertebral block for postoperative analgesia and quality of recovery following daytime laparoscopic partial adrenalectomy. 2. Study design

2.1. Type of the study

The research is a single-center, double-blind, randomized-controlled clinical trial.

2.2 Sample size calculation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to70 years
  • Body Mass Index (BMI) 18.5 to 30 kg/m²
  • American Society of Anesthesiologists (ASA) grade I to II classification
  • unilateral non-functional adrenal adenoma with a tumor diameter greater than 20mm

排除标准

  • Patients with peripheral nervous system disease
  • Patients with spinal deformity or surgery
  • Patients with puncture site infection or coagulation abnormalities
  • Patients with history of postoperative nausea and vomiting or allergy to local anesthetics
  • Patients with unstable mental illness or refusal to participate

结局指标

主要结局

Quality of Recovery

时间窗: 24 and 48 hours postoperatively

quality of recovery, measured using the 15-item Quality of Recovery questionnaire (QoR-15), It ranges from 0 to 150, with a higher score indicating a better quality of recovery

次要结局

  • Opioid consumption(48 hours postoperatively)
  • Rate of remedial analgesia(48 hours postoperatively)
  • Times to first flatus and defecation(48 hours postoperatively)
  • pain scores at rest and during coughing(1, 6, 12, 24, and 48 hours after surgery)
  • Postoperative gastrointestinal function outcomes(12, 24, and 48 hours after suegery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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