Does the Transversalis Fascia Plane Block Work Better Than the Transversus Abdominis Plane Block for Relieving Pain After a Robotic-assisted Partial Prostatectomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Reducing patient-controlled analgesic consumption
研究概览
简要总结
Regional anesthetics, nerve blocks, and interfascial blocks are becoming more common in many types of surgery to help with pain after surgery. Most clinicians concur with the importance of reducing postoperative pain scores and facilitating early discharge. The transversalis fascia plane block (TFP) and transversus abdominis plane block (TA), which are done from the side of the abdomen, have been proven to be very useful in surgeries related to women's health, weight loss, and the colon. Research on the effectiveness of both procedures in robot-assisted laparoscopic prostatectomies (RALP) is insufficient. The aim was to see if using a transversalis fascia plane block (TFP) or a transversus abdominal plane (TAP) block with 0.25% bupivacaine helped reduce pain, speed up recovery, and shorten hospital stays for men undergoing robot-assisted radical prostatectomy (RALP).
详细描述
Regional anesthetics, nerve blocks, and interfascial blocks are becoming more common in many types of surgery to help with pain after surgery. Most clinicians concur with the importance of reducing postoperative pain scores and facilitating early discharge. The transversalis fascia plane block (TFP) and transversus abdominis plane block (TA), which are given from the side of the abdomen, have been found to be very useful in surgeries related to women's health, weight loss, and the colon. Research shows that both procedures are ineffective in robot-assisted laparoscopic prostatectomies (RALP).
In this study, doctors will start general anesthesia using propofol and rocuronium as usual and keep it going with a mix of 4-6% desflurane with oxygen, remifentanil, and rocuronium given through an IV.
All procedures will be conducted within the framework of an observational clinical research protocol, and patients will not be subjected to any procedures outside of routine practices.
Before starting the study, patients will be thoroughly informed, and their written consent will be obtained. The study is planned to start in May 2025.
Patients will be examined in the anesthesia outpatient clinic for preoperative evaluation. Demographic data (age, gender, ASA score, height, weight, BMI, and comorbidities) will be recorded in the preoperative patient evaluation form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) Class I or II
- •Having regular preoperative visits
排除标准
- •Patients classified as ASA III or IV,
- •Patients with coagulopathy
- •Those with a history of allergies
- •Significant Cardiac Disorders (Coronary Artery Disease, Arrhythmia, Electrocardiography Anomaly, Heart Failure, etc.)
- •1. Those with bleeding diathesis and those receiving anticoagulant therapy
- •Those with a history of carotid artery stenosis,
- •Cardiovascular disease,
- •Hipertansiyon,
- •Chronic obstructive pulmonary disease,
- •Patients with a heart rhythm outside the sinus
- •Patients with a history of cerebrovascular disease
- •Alcoholism or psychiatric illness
- •Those with diabetes,
- •Contraindicated for TAP and TFP Block
- •Those with drug allergies
研究组 & 干预措施
Control Group
Not receiving TAP or TFP
TAP Group
Receiving TAP 20 ml bupivacaine 0.25%
干预措施: TAP Plane Block (Procedure)
TFP Group
Receiving TFP 20 ml bupivacaine 0.25%
干预措施: TFP Block (Procedure)
结局指标
主要结局
Reducing patient-controlled analgesic consumption
时间窗: From the patient's anesthesia induction in the operating room to the postoperative 24. hours
The time to first analgesic request in the postoperative period
次要结局
未报告次要终点
研究者
Kudret Dogru
Prof. Dr. (MD)
TC Erciyes University