Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Versus Incisional Local Anesthetic Administration for Total Laparoscopic Hysterectomy : a Prospective, Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative total tramadol consumption for first 24 hours
研究概览
简要总结
The aim of the study is comparing the postoperative effects of ultrasound-guided Modified Perichondrial Approach to Thoracoabdominal Nerves (M-TAPA) block for postoperative pain control after total laparoscopic hysterectomy.
详细描述
Pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy.
Multimodal analgesia methods are used in postoperative pain management. Nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today.
Local Anesthetic Infiltration at the Trocar Site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries.
Modified TAPA block applied with ultrasound guidance; It is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. It is used in total laparoscopic hysterectomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Ages 18-65
- •Elective cases
- •ASA I-III functional status
- •Body mass index (BMI)<35
- •Total laparoscopic hysterectomy planned with general anesthesia
- •No contraindications for M-TAPA block to be applied
- •Cases that give written and verbal consent for participation in the study will be included.
排除标准
- •Conversion to open surgery
- •Development of perioperative complications (due to surgery and/or anesthesia)
- •Coagulation disorder
- •Infection at the injection site
- •Allergy to local anesthesia
- •Those who used any painkillers in the preoperative 24 hours
- •Those who did not agree to participate in the study
结局指标
主要结局
Postoperative total tramadol consumption for first 24 hours
时间窗: Postoperative 24 hours
The intravenous PCA pump will be programmed to deliver a bolus of 20 mg tramadol with a lockout interval of 30 min and no baseline infusion (tramadol 500 mg in 100 mL SF
次要结局
- Postoperative pain scores(at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours)
研究者
ELA ERTEN
medical doctor
Gulhane Training and Research Hospital