Comparison of Ultrasound-guided Bilateral Subcostal TAP Block with a combination of Port site Infiltration and Intraperitoneal instillation OF postoperative analgesia in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To estimate the duration of postoperative analgesia
研究概览
简要总结
120 patient who meet the inclusion criteria will be allocated into 2 groups by computer generated randomization.
GROUP :A Ultrasound guided Subcostal TAP Block
GROUP :B Port site infiltration and intraperitoneal instillation.
All patients will be premedicated with tab.Alprazolam 0.5 mg preoperatively ,2 hours before shifting to operation theatre. Patients vitals will be monitored with pulse oximetry ,NIBP and ECG.
All patients will receive general anesthesia with endotracheal intubation which will be standardized
Patients will be induced with Propofol 2 mg /kg and Vecuronium 0.1 mg/kg as the muscle relaxant . Fentanyl 2 mcg/kg will be used as the intraoperative analgesia. Anesthesia will be maintained with Sevoflurane and Vecuronium.
After induction of anesthesia , the patient will receive either ultrasound -guided bilateral subcostal TAP Block(GROUP:A) or the combination of port site infiltration and intraperitoneal instillation(GROUP:B)
GROUP:A Bilateral Subcostal TAP Block will be performed under ultrasound vision ( Logic V2 GE Ultrasound ), using a 6 to 15- HZ high - frequency linear probe and a 100- mm needle with the patient lying in supine decubitus position. 20 ml of 0,25 % Ropivacaine will be deposited in each side.
GROUP:B 5 ml of 0.25% Ropivacaine will be infiltrated in each port site before insertion of the trochar. In addition after creation of pneumoperitoneum , the operating surgeon will be asked to instill 20 ml of 0.25% Ropivacaine propotionately over the gall bladder, liver surface and the patient peritoneum on the undersurface of the diaphragm before starting the dissection.
The patient will be extubated at the end of surgery and shifted to recovery. The patient will be shifted to PACU when Aldrete recovery criteria are satisfied .The patient will be continiously monitored in PACU for 24 hours.
The pain will be assessed by Visual Analog Scale
0 : NO PAIN
1-2 : MILD PAIN INTENSITY
3-5 : MODERATE PAIN INTENSITY
6-8 : SEVERE PAIN INTENSITY
9-10 : WORST PAIN
The duration of postoperative analgesia is defined as the time taken from the completion of block or infiltration to the first request for the postoperative analgesia (VAS >3)
The patient will be started on the patient control analgesia using morphine with a bolus dose of 1mg and lockout interval of 10 minutes.
The total consumption of morphine will be noted . The occurance of any adverse effects like nausea , Vomiting , itching and respiratory depression will be noted and treated accordingly
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with ASA Physical Status I and II posted for laparoscopic cholecystectomy 2.Weighing between 50 – 100 kg.
排除标准
- •1.All patients with ASA Physical Status III and above 2.Patients who refuse to participate in the study 3.Patients who are allergic to amide local anaesthetics 4.Patients who are pregnant 5.Patients with chronic cardiac, renal or hepatic condition 6.Patients with coagulation abnormalities.
结局指标
主要结局
To estimate the duration of postoperative analgesia
时间窗: patient is assessed for pain second hourly using Visual Analogue Scale for 24 hours
次要结局
- 1.To estimate the Consumption of morphine in 24 hour postoperative period(2.Intraoperative consumption of opioids)