Comparison of the Efficacy of Bilateral Transverse Abdominis Plane Block (TAPB) and Bilateral Quadratus Lumborum Block (QLB) With Intravenous Analgesic (IVA) Group for Preemptive Analgesia in Laparoscopic Cholecystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- postoperative total tramadol consumption
研究概览
简要总结
Patients who will undergo laparoscopic gallbladder surgery are expected to experience less postoperative pain and have less need for morphine-derived painkillers.
For this reason, a total of 128 patients were planned to be included in the study, including a group of patients who were eligible for gallbladder surgery with transverse abdominis plane block (TAPB), a group of patients with quadratus lumborum plane block (QLB) and a group of patients with intravenous painkillers (IVA).
详细描述
- Group QLB (Quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Group TAPB (Transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
For both Group QLB and Group TAPB block group;
- Medical records will be audited to monitor adherence to the intervention.
- each patient will be administered 0.25% bupivacaine for each side (a total of 40 ml of 0.25% bupivacaine will be used)
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
- Both plane blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
- Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia.
- Postoperative evaluations of patients will be performed face to face.
- Plane block applications will be applied only once in the preoperative period.
- In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.
- This study will be followed up in the general surgery unit.
- Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
Statistical methods / analysis: Power analysis (G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.
SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Aged 18-70 years,
- •who will undergo laparoscopic cholecystectomy and who meet the American Society of Anesthesiologists (ASA) I-III physical status
排除标准
- •American Society of Anesthesiologists (ASA) physical status above 3
- •Age < 18 or >70 years
- •patient's reluctance
结局指标
主要结局
postoperative total tramadol consumption
时间窗: during the first 24 hours after surgery.
Amount of tramadol used postoperatively (milligrams). If the VAS value of the patients is 4 and above, 100 mg tramadol is administered intravenously.
VAS value of abdominal pain
时间窗: 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
次要结局
- amount of fentanyl consumed during the operation(during surgery)
- nausea-vomiting(30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated)
- postoperative shoulder pain(30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated)
- length of hospital stay(It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first)
- Sedation- agitation level(during extubation)
- surgical duration(at the end of surgery)
- anaesthesia duration(at the end of anaesthesia)
研究者
Fatma Acil
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
