Laparoscopic-assisted Transversus Abdominis Plane Block for Post-laparoscopic Cholecystectomy Pain: A Prospective Double-blind Randomized Study '' .
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is a minimally invasive surgical procedure that causes moderate pain in the early postoperative period. In this prospective randomized study, the efficacy of four-quadrant and two-quadrant laparoscopic-assisted transversus abdominis plane (LTAP) block on postoperative pain will be compared with that of only intravenous analgesia (SA) and port-site infiltration of local anesthetic (LA).
Patients undergoing elective LC will be divided into four groups of 40 patients each using a randomization scale. The standard analgesia group will receive LTAP block with normal saline (NS) and port-site infiltration of NS, the LA group will receive LTAP block with NS and port-site infiltration of bupivacaine, while the four and two quadrant LTAP group will receive the block with bupivacaine and port-site infiltration of NS. Postoperative analgesia will be administered to all groups as a standard procedure. The patients' demographic data, postoperative 1, 3, 6, 12, and 24-hour visual analog pain (VAS) scores at rest and on cough, opioid requirement, presence of nausea and vomiting, and satisfaction scores will record in a standard form. The statistical analysis will be carried out using the SPSS software and the level of significance was set at p<0.05.
详细描述
This prospective, randomized, controlled, observer and patient-blind study will be conducted by the General Surgery, Anesthesiology and Reanimation Departments of Private Medicabil Hospital in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. Hospital ethics committee approval was obtained for the study and the study was conducted between january 2021 and april 2020. Informed consent for the study to be conducted will obtained from each patient.
Study Inclusion and Exclusion Criteria The study will included American Society Anesthesia (ASA) 1 and 2 patients aged 18-70 years who underwent conventional four-quadrant LC.
Exclusion criteria:
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Patients who did not agree to participate in the study,
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ASA 3 and above patients, those who will undergone emergency surgery, open cholecystectomy
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BMI of >40,
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İntraoperative major complications,
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History of severe allergy,
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Chronic analgesic use, Study Parameters
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gender, age, presence of comorbidity, weight, height, smoking status, operative time, length of hospital stay, intraoperative fluid volume, and developed complications 2. the primary data of the study: the postoperative 1, 3, 6, 12, and 24-hour VAS scores (0 lowest-10 highest) at rest and on cough after surgery 3. the rate of rescue analgesic dose of tramadol 4. as the secondary data: nausea-vomiting, shoulder pain, discharge duration exceeding 24 hours, and pre-discharge patient satisfaction (strongly disagree 1-strongly agree 5 on a Likert-type scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Anesthesia team, the patient, and the clinical nurses who carry out and record the postoperative evaluation will blinded to the group of patients.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society Anesthesia (ASA) 1 and 2 patients aged 18-70 years
排除标准
- •Patients who did not agree to participate in the study,
- •ASA 3 and above patients, those who will undergone emergency surgery, open cholecystectomy
- •BMI of >40,
- •İntraoperative major complications,
- •History of severe allergy,
- •Chronic analgesic use,
结局指标
主要结局
Pain score
时间窗: postoperatively 1,3,6,12 and 24 hours
he postoperative 1, 3, 6, 12, and 24-hour VAS scores (0 lowest-10 highest) at rest and on cough after surgery
次要结局
- satisfaction score(postoperatively 24 hours)
研究者
Halil Özgüç
staff of general surgery
Private Medicabil Hospital