To evaluate post operative shoulder tip pain in low pressure (less than or equal to 10mmHg CO2) pneumoperitoneum versus standard pressure (13-15 mmHg CO2) pneumoperitoneum in laparoscopic cholecystectomy, a randomized controlled trial study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Laparoscopic cholecystectomy, is one of the most frequently performed abdominal operations. During this procedure, carbon dioxide gas is used to inflate the abdomen to create space for surgery. Although minimally invasive, many patients experience post-operative shoulder pain, which can cause discomfort, delay mobilization, and increase the need for pain medications. This shoulder pain is believed to occur due to irritation of the diaphragm caused by the gas used during surgery.
Traditionally, laparoscopic cholecystectomy is performed using standard gas pressure. However, recent studies suggest that using a lower gas pressure may reduce post-operative shoulder pain without affecting the safety or effectiveness of the surgery.
This randomized controlled trial aims to compare post-operative shoulder pain in patients undergoing laparoscopic cholecystectomy using low gas pressure (less than or equal to 10 mmHg) versus standard gas pressure (13–15 mmHg). Eligible patients will be randomly assigned to one of the two groups. Shoulder pain severity will be assessed using a standardized pain scale at regular intervals after surgery. Other outcomes such as overall pain, need for pain medication, duration of surgery, and any complications will also be recorded.
The findings of this study may help identify a simple and cost-effective method to improve patient comfort after laparoscopic gallbladder surgery without compromising surgical safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged 18 years and older and undergoing elective Laparoscopic Cholecystectomy.
- •Participants represent various age group and gender.
- •They are capable of expressing pain and have sufficient language and communication skills to provide informed consent and complete assessments.
排除标准
- •1.Conversion to open cholecystectomy 2.Acute inflammation or any other complication of gall stone disease.
- •3.Choledocholithiasis 4.Any intra-operative or post-operative complication such as bile duct injury, bile duct obstruction, intra-operative discovery of bile duct anomalies, infection and fever.
- •Substance Abuse: Exclude individuals with a history of substance abuse or dependence, as substance use may impact pain tolerance.
- •Patient Post operatively shifted to ICU and High Dependency Unit.
- •Inability to Provide Informed Consent: Exclude individuals who are unable to provide informed consent due to cognitive impairment or other reasons, as they may not fully understand the study procedures or risks involved.
- •Patients with significant portal hypertension, coagulopathies, suspected gall bladder carcinoma, cirrhosis or generalised peritonitis.
研究者
Darshan A N
Dr Rajendra Prasad Government