Effectiveness of Modified-Thoracoabdominal Nerve Block With Perichondrial Approach (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy Surgery: A Prospective, Randomized, Double-Blind, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery.
Participants will be randomly assigned to one of two groups:
The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins.
The Control Group: Patients will receive standard postoperative pain management without the nerve block.
The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years
- •ASA (American Society of Anesthesiologists) physical status I, II, or III
- •Scheduled for elective laparoscopic hysterectomy
- •Voluntary participation with signed informed consent
排除标准
- •Hepatic or renal disease.
- •Coagulation disorders.
- •Uncontrolled cardiovascular or respiratory diseases.
- •Psychiatric disorders.
- •History of allergy to local anesthetics.
- •History of alcoholism, drug or substance abuse.
- •Body Mass Index (BMI) greater than 35 kg/m2
- •Refusal of the regional block procedure
研究组 & 干预措施
Control Group
M-TAPA Group
干预措施: Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA) (Procedure)
结局指标
主要结局
Morphine consumption
时间窗: First 24 hours postoperatively
Total amount of morphine (mg) used via Patient-Controlled Analgesia (PCA)
次要结局
- Postoperative Pain Scores (NRS)(Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively)
- Rescue analgesic drug consumption(Within the first 24 hours postoperatively)
- Incidence of postoperative nausea and vomiting(Within the first 24 hours postoperatively)