Comparison of efficacy of Intraperitonial nebulisation versus Intraperitonial instillation of Ropivacaine for post operative pain management in patients undergoing laparoscopic cholecystectomy under general anaesthesia .
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
Dr Riya bishnoi
Mahatma Gandhi Medical College And Hospital
