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临床试验/CTRI/2024/07/070339
CTRI/2024/07/070339尚未招募不适用

Opioid Free Anaesthesia In Pancreatico-Duodenectomy- Single Centre Prospective Observational Study

Basavatarakam Indo American Cancer hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35
试验地点
1
主要终点
1. To assess the no of patients requiring rescue opioid medications and the amount of opioid required in intravenous fentanyl equivalent

研究概览

简要总结

Pancreatic cancer is an intractable malignancy and is ranked as the seventh leading cause of cancer related deaths worldwide as per the GLOBOCAN 2018  estimates , with a 5 yr survival rate of 9%despite advances in medical therapy. Pancreatico-duodenectomy also known as the whipples’procedure is the surgical procedure of choice for resectable pancreatic carcinomas.

opioids has been considered as the mainstay for pain management following pancreatic tumour resections, resulting in opioid related adverse effects like respiratory  depression , narcotic dependence , delayed gastric empyting and post-operative ileus, increased length of hospital stay cost burdern.

They also have a profound potential for developing addiction , which is currently an epidemic in united states and overdose deaths from from synthetic opioid drugs have been skyrocketing over the last decade .

Therefore in solidarity of ERAS society recommendation , every effort to minimize opioid usage with implementation of opioid free anesthesia (OFA )strategies has to be considered.

Thus this study proposes the idealogy tht OFA strategy should be favoured in order to reduce the opioid relate adverse effects and improve perioperative pain management and recovery with multimodal analgesia .

AIiming To assess the feaseability of opioid free anesthesia for pancreatico-duodenal surgery

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA status from 1to 3
  • Surgery whipples procedure.

排除标准

  • Local anaesthetic allergy
  • Infection at injection site
  • Coagulopathy
  • Critical coronary artery disease
  • Renal dysfunction 7.

结局指标

主要结局

1. To assess the no of patients requiring rescue opioid medications and the amount of opioid required in intravenous fentanyl equivalent

时间窗: 0 min, 30 mins , 60 mins, 90 mins , 120 mins , 4th hr , 6th hr , 8th hr, 12th hr, 24th hr , 28th hr, 32th hr, 36th hr, 40th hr, 44th hr, 48th hr, 52th hr, 56th hr, 60th hr, 64th hr, 68th hr, 72th hr

次要结局

  • 1. To assess changes in intraoperative hemodynamics i.e., before and after skin incision.(2. To assess the incidence post extubation post operative complication according to Clavein-Dindo classification)

研究者

发起方
Basavatarakam Indo American Cancer hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Taseen Mahvish

Basavatarakam Indo American Cancer Hospital And Research Institute

研究点 (1)

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