Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) Post-Operative Analgesia Compared To Intravenous Opioids In Laparoscopic Cholecystectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.
研究概览
简要总结
The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Study participants will be divided into 2 groups, namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach (M-TAPA) block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively. Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief, reduce the pain scale, and the total dose of pain medication needed postoperatively. The injection of this peripheral nerve block drug will be carried out by an anesthesiologist. Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards. This study will last up to 24 hours after surgery.
The main question it aims to answer is:
To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group.
详细描述
A. Treatment of patients in P1 and P2 before entering the operating room:
- Every patient who meets the eligibility criteria will be asked for consent to become a subject of this study. Proof of consent is the signing of a letter of willingness to become a subject of the study by the informant, the consent giver, and one witness. Quality of Recovery using QoR 40 form will evaluate before surgery and 24 hours after surgery.
- Patients have been fasted for 8 hours from solid food before surgery, clear water up to 2 hours before surgery. The infusion is installed 2 hours before the patient is sent to the operating room using an 18G intravenous catheter with Ringer lactate fluid at a rate of administration according to the patient weight 10 ml/kg/hour
B. Treatment of patients in the operating room P1 and P2:
- General anesthesia was performed in both groups.
- General anesthesia begins with preoxygenation for 3-5 minutes with 100% O2.
- Continued induction using intravenous propofol 2 mg/kgBW and intravenous fentanyl 2 mcg/kgBW.
- After the patient is induced, continue by giving the muscle relaxant atracurium 0.5 mg/kgBW intravenously.
- After three minutes, laryngoscopy and intubation are performed using an endotracheal tube (ETT) with a size according to the patient needs.
- Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter: 1 liter and sevoflurane.
- All patients were performed with the same laparoscopic cholecystectomy procedure (4-port technique), umbilical port (5mm), infraxiphoidal (15-20 mm), lateral intersection of the umbilicus and axillary line (5 mm), and symmetrical assistant port (5 mm). With a pneumoperitoneum pressure of 10-12 mmHg.
- Continue with the operation until completion. One hour before the surgery is completed, the patient is given anti-vomiting prophylaxis ondansetron 0.1 mg/kgBW intravenously.
Group P1:
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient 18-65 yeasr old
- •IMT 17.5-30 kg/m2
- •Patient with ASA I-II
排除标准
- •Patient Refusal
- •Local Infection
- •Chronic Analgesia drug user
结局指标
主要结局
Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.
时间窗: 24 hours
Evaluate total PCA Intravena opioid consumption (morphin in mg) delivered dose.
次要结局
- Numeric rating Scale(24 hours)
- QoR 40(24 hours)
研究者
amelia christiana
Principle Investigator
Udayana University