跳至主要内容
临床试验/CTRI/2024/08/072728
CTRI/2024/08/072728尚未招募2 期

Effectiveness of intraperitoneal instillation of normal saline in reducing shoulder tip pain following laparoscopic cholecystectomy.

Anshul1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年8月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
1. To assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy.

研究概览

简要总结

Patient who are found fit in preanesthetic checkup will be posted for laparoscopic cholecystectomy. Laparoscopiccholecystectomy will be performed after creating pneumoperitoneum with carbon dioxide insufflation under standard pressure of 12 mmHg. After removing gall bladder as per standard surgical technique patient in the intervention group will receive intraperitoneal instillation of normal saline at body temperature in the right hemidiaphragmaticarea until the whole liver is submerged. After irrigating, whole of intraperitoneal fluid in group A will be evacuated by negative suction drainage whereas in other group no such instillation of normal saline will be done. After performing the procedure all port site will be closed. Patient where drain has been put will be excluded from the study. After performing procedure right shoulder tip pain will be assessed at 6, 12, 24 and 48h using visual analogue scale (VAS). In which pain intensity score of 0 represents no pain, 1-3 mild pain , 4-6 moderate pain, 7-10 indicates severe pain23. The pain scores using VAS will be entered on patient’s proforma. Both the patient and observer willbe blinded to the type of intervention the

patient has received. Data will be recorded concerning duration of surgery, bile spillage during operation, frequencyand intensity of shoulder-tip pain.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18 and 65 years of age with an American Society of Anesthesiologists physical status classification of I-II (ASA classification) who are scheduled to undergo an elective laparoscopic cholecystectomy can participate in the study.

排除标准

  • Conversion to open cholecystectomy
  • Patients in whom abdominal drain have been put after laparoscopic cholecystectomy.
  • Pre-existing shoulder pain which is based on doctor evaluation and clinical report before the study.
  • Pre-existing liver disease
  • Any biliary spillage in control group.

结局指标

主要结局

1. To assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy.

时间窗: 1. To assess the incidence of post-procedure shoulder tip pain at 6, 12, 24 and 48h after elective laparoscopic cholecystectomy.

次要结局

  • 2. To determine role of intraperitoneal instillation of normal saline in reducing severity of post laparoscopic shoulder tip pain.(72 hours)

研究者

发起方
Anshul
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anshul

GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH

研究点 (1)

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