Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy: A Prospective Randomized Double-Blind Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Control
研究概览
简要总结
Title: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy
Brief Summary:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. The study is a prospective, randomized, double-blind, placebo-controlled trial involving 90 patients aged 18 to 65 years, with ASA I or II physical status, scheduled for single-port laparoscopic surgery lasting less than 2 hours. Participants are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at multiple time points. Secondary outcomes include opioid consumption, effective activations of the analgesia pump, and postoperative recovery parameters such as time to mobilization and length of hospital stay. The study hypothesizes that preoperative ultrasound-guided bilateral RSB will significantly improve postoperative
详细描述
Background:
Gynecological single-port laparoscopy has become a preferred surgical approach due to its minimal trauma, concealed scarring, and rapid postoperative recovery. However, postoperative pain and slow recovery of gastrointestinal function remain challenges. Traditional analgesic protocols often rely on opioids, which can cause adverse effects such as nausea, vomiting, bowel paralysis, and respiratory depression.
Objective:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy.
Methods:
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)
盲法说明
The study was designed as a double-blind trial, ensuring that neither the patients nor the operating surgeons were aware of the group allocations throughout the study. This blinding was critical to eliminate bias in treatment administration and outcome assessment, thereby enhancing the validity of the trial results.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years
- •Physical status classified as I or II according to the American Society of Anesthesiologists (ASA)
- •Surgical durations of less than 2 hours
排除标准
- •Infection at the planned puncture site
- •Neurological disorders or nerve injuries
- •Conversion to open surgery for various reasons during the procedure
- •Coagulation abnormalities
- •Patients had the option to withdraw from the study at any time if they chose not to continue their participation.
结局指标
主要结局
Postoperative Pain Control
时间窗: 48 hours post-surgery
ssessment of postoperative pain using the Visual Analog Scale (VAS) scores at multiple time points (30 minutes, 6 hours, 12 hours, 24 hours, and 48 hours after surgery).
次要结局
- Intraoperative Opioid Consumption(Intraoperative)
- Postoperative Recovery Parameters(From postoperative to discharge)
- Adverse Event Rates(48 hours post-surgery)
研究者
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital