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临床试验/CTRI/2025/12/099747
CTRI/2025/12/099747尚未招募不适用

Comparison of efficacy of Intraperitonial nebulisation versus Intraperitonial instillation of Ropivacaine for post operative pain management in patients undergoing laparoscopic cholecystectomy under general anaesthesia .

India educational trustdepartment of anesthesiaMahatma Gandhi medical college and hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月2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
80
试验地点
1

研究概览

简要总结

Laparoscopic cholecystectomy is the preferred approach for gallbladder removal as it is

minimally invasive procedure and associated with many advantages over open surgery [1].

.Although laparoscopic surgeries are associated with reduced postoperative pain, reduced hospital

stay and faster recovery compared to open procedures, still patients often experience significant

discomfort and pain especially in the early postoperative period. Effective management of

postoperative pain is crucial not only for patient-comfort but also for reducing the risk of

complications, enhancing recovery, and facilitating early discharge. [2].

Pain experienced after laparoscopic cholecystectomy is mainly felt due to intraperitonial

insufflation of carbon dioxide resulting in the peritoneal stretching and Somatic pain from trocar

sites. shoulder pain resulting from diaphragmatic irritation due to retention of CO2

pneumoperitoneum is commonly observed postoperative period [4]

Administration of intraperitoneal local anasthetic in laparoscopic surgeries as part of a multimodal

approach to post op-Operative pain management is safe, but intraperitoneal instillation provides

limited pain relief [4]. Failure to achieve adequate pain-relief after intraperitoneal local anaesthetic

instillation may be attributed to the non-uniform distribution of local Anaesthetic throughout the

peritoneal surface [5]

Intraperitoneal mist instillation, a novel technique for drug administration, aims to achieve

uniform dispersion of local anaesthetic particles measuring 0.3 microns throughout the

peritoneal cavity. This procedure involves utilising the Aerogen Pro® device, which is

connected between the insufflator and the insufflation tubing. Tubing is then attached to the

umbilical port. The initiation of mist instillation coincides with the commencement of

laparoscopic gas insufflation, ensuring simultaneous and efficient dispersion of the

local anaesthetic particles.

Intraperitoneal mist instillation of Ropivacaine offers benefits such as reduced opioid

consumption, improved pain control, and faster recovery compared to traditional pain

management methods alone.

This randomised controlled trial aims to compare the efficacy of intraperitonial ropivacaine instillation

and intraperitonial ropivacaine nebulisation with aerogen pro device in laparoscopic

cholecystectomy.

Thus, we have designed a double blinded study and hypothesised that Intraperitoneal mist

instillation of Ropivacaine may offer better postoperative analgesia as compared to Intraperitonial

instillation

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients aged 18–60 years ASA (American Society of Anaesthesiologists) physical status I and II Undergoing elective laparoscopic cholecystectomy under general anaesthesia Willing to provide informed consent.

排除标准

  • Known allergy or hypersensitivity to local anesthetics Chronic opioid use or chronic pain conditions Conversion to open surgery Pregnancy or lactation.

研究者

发起方
India educational trustdepartment of anesthesiaMahatma Gandhi medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Riya bishnoi

Mahatma Gandhi Medical College And Hospital

研究点 (1)

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