跳至主要内容
临床试验/NCT03790007
NCT03790007已完成4 期

COMPARISON OF INTRAOPERATIVE TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHESIA APPLICATION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
3
试验地点
1
主要终点
Level of postoperative pain: visual analogue scale

研究概览

简要总结

Since 1987, laparoscopic cholecystectomy has become the standard procedure for gallbladder stones and lesions. Complications due to improvements in laparoscopy and increased surgical experience have decreased day by day, but there is still a problem in terms of postoperative pain management. Several pain management procedures have been tried to combat pain after laparoscopic cholecystectomy. The aim of this study is to decrease the length of hospital stay, to increase the comfort of the patient and to reduce the cost of treatment. Local anesthetic injection to port locations, intraperitoneal periportal local anesthetic injection ,Transversus Abdominis Plane Blok and without any local anesthetic application to the control group compared to the group's analgesic efficiency and to reduce the amount of analgesics needed, shorten the length of hospital stay and improve patient comfort.

详细描述

Laparoscopic cholecystectomy procedure will be performed in patients older than 18 years of age for the diagnosis of cholelithiasis. Laparoscopic cholecystectomy procedure will be performed.4 patients group will be formed Power: 0.80 and alpha: :0.05 The minimum number of samples determined for each group is n: 34 for each group. It will be determined. In our clinic, local anesthetic injections are performed routinely to the trocar areas in laparoscopic cholecystectomy operations. After endotracheal intubation at the beginning of the operation, after appropriate skin staining and sterile dressing, Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied. to the second group local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution) to be applied, in the third group intraperitoneal direct vision of the gallbladder area-periportal area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc saline, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied. The fourth group will be the control group and any of these methods will not be applied, the operation time and peroperative complications (pouch perforation etc.) will be recorded. Paracetamol 1 g + 1 mg / kg tramadol IV will be applied to all four groups as standard before extubation. Visual analogue scale (VAS) will be applied to all patients in the postoperative period. If VAS> 3 is still present, a dose of 1 mg / kg tramadol will be administered. Tenoxicam 1x1 IV will be applied to the patients on the 12th hour. All patients were postoperative; 1,2,4,6,12,24. VAS scores , patient satisfaction (0: never satisfied, 5: very satisfied) will be recorded. The group of patients will be determined according to the order of surgery. Pain scores of the patients will be performed by a physician who is not in the operation who does not know which group is taken. The patients included in the group will not be known to the patient by the pain scoring system and the study will be done as double blind. Patients will be randomized with this method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

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

入选标准

  • Patients over 18 years of age who were admitted to the general surgery department with the diagnosis of cholelithiasis

排除标准

  • Patients who need to undergo peroperative open cholecystectomy procedure.
  • Patients with local anesthetic or NSAID allergy
  • Patients in pregnancy
  • Patients who are breastfeeding
  • Patients with connective tissue disease
  • Patients with malignancy in postoperative gallbladder pathological examination and patients with any malignancy diagnosis
  • Patients with renal impairment, where the effect of using Marcain is unknown
  • Cardiac disease
  • Patients with hepatic impairment

研究组 & 干预措施

Transversus Abdominis Plane Block

Active Comparator

Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.

干预措施: Bupivacaine (Drug)

TROCHAR SITES LOCAL ANESTHETIC INJECTION

Active Comparator

local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)

干预措施: Bupivacaine (Drug)

INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD

Active Comparator

Intraperitoneal direct vision of the gallbladder excision area-periportal area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc SF, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Level of postoperative pain: visual analogue scale

时间窗: 24 hours

the level of the pain will be assessed using the VAS ( visual analogue scale) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) that best reflects the intensity of their pain. The pain measurements will be done at 1,2,4,6,12,24 hours. Test is easy to obtain, reliable, valid and can detect changes of over time

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANIL ERGIN

asistant doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

Loading locations...

相似试验