跳至主要内容
临床试验/CTRI/2025/12/099594
CTRI/2025/12/099594尚未招募不适用

Comparative study of intravenous paracetamol and intravenous tramadol for post operative analgesia in laparoscopic cholecystectomy

Peoples Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1

研究概览

简要总结

The prospective study will be conducted from 1st Sept 2025 to 28th Feb 2027 after approval from the Institutional Ethics Committee

Informed written consent will be obtained from every participant in the study

Adult patients between 18 to 55 years of age ASA I or ASA II who will be scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled

Patients will be receiving analgesic as per prescription of the operating surgeon and investigator will not be deciding the analgesic Investigator will only observe the results once analgesic is used

The patients will be divided into two groups

Group A Patients who will receive intravenous Paracetamol 1g in 100 ml solution

Group B Patients who will receive intravenous Tramadol 100 mg in 100 ml NS

After surgery, initial dose of analgesic either Tramadol 100 mg intravenous or Paracetamol 1g intravenous will be given ondemand to the patients in the postoperative period Thereafter Tramadol 100 mg or Paracetamol 1g intravenous infusion will be given at 8 th 16 and 24 hours

Pain intensity will be measured based on a 10 point Visual Analogue Scale  VAS 0 to 10 cm 0 no pain and 10 worst imaginable pain

VAS pain scores will be obtained postoperatively at just after the operation T0 before analgesic administration and 30 minute after the administration of intravenous paracetamol or intravenous tramadol at 8hour T1 and T2 16th hour T3 and T4 and 24 hour T5 and T6 duration

Any pain score above 5 on VAS will be considered a breakthrough pain It will be managed by rescue analgesia with intravenous Diclofenac sodium 1.5 mg per kg in 100 ml NS repeated as required

Observe and to be noted any adverse events of nausea vomiting and pain at intravenous site with intravenous paracetamol and intravenous tramadol

Collection of all data will be done in EXCEL SHEET and then will be analyzed using SPSS software

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA physical states stage one and Two BMI less than 40 kg per meter square Patients posted for elective laparoscopic cholecystectomy.

排除标准

  • Emergency Cholecystectomy If the surgery required conversion to open Cholecystectomy Known hypersensitivity to paracetamol and tramadol Daily intake of analgesics or steroids within two weeks surgery Pregnant women and Lactating women Patients with ASA physical states stages greater than 2.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prachi Thakur

PCMS and RC bhopal

研究点 (1)

Loading locations...

相似试验

Study of two medicines IV paracetamol and IV... | 临床试验