Effect of Ultrasound Guided vs Conventional Port Placement on Postoperative Port-Site Pain in Laparoscopic Cholecystectomy: A Single Blinded Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, single centre, single blinded randomized controlled trial conducted at All India Institute of Medical Sciences, Gorakhpur. The aim is to compare ultrasound guided port placement with conventional port placement in patients undergoing elective laparoscopic cholecystectomy.
A total of eligible adult patients will be randomly allocated into two groups, namely the ultrasound guided group and the conventional group. Pain severity will be assessed using the Visual Analogue Scale at 2, 6, 12, 24, and 48 hours after surgery. The primary objective is to determine whether ultrasound guided port placement reduces postoperative port site pain within the first 48 hours.
Secondary objectives include comparison of total postoperative analgesic requirement, time to first ambulation, and incidence of port site complications such as hematoma, bleeding, infection, and seroma up to postoperative day 30.
The study is expected to demonstrate that ultrasound guided port placement reduces postoperative pain, decreases analgesic consumption, lowers complication rates, and facilitates earlier ambulation, thereby improving overall recovery and potentially influencing future surgical practice.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged between 18 and 60 years 2) American Society of Anaesthesiologists (ASA) physical status classification of I to III 3) Scheduled for elective LC 4) Patients who provide informed consent to participate in the study.
排除标准
- •Patients undergoing emergency laparoscopic procedures will be excluded.
- •Individuals with a history of previous upper abdominal surgery or trauma will be excluded.
- •Patients with known coagulopathies, defined as an International Normalized Ratio greater than 1.5 or a platelet count below 50,000, will be excluded.
- •Pregnant females will be excluded.
- •Patients with morbid obesity, defined as a body mass index equal to or greater than 35 kilograms per square meter, will be excluded.
- •Patients with cognitive impairment or inability to provide informed consent will be excluded.
- •Patients who are unable to comprehend or use the Visual Analogue Scale for pain assessment will be excluded.
- •Patients with local skin infection at the proposed port sites will not be enrolled.
- •Cases requiring open conversion during surgery will be excluded.
- •Patients on long term medications that may alter pain perception, such as antidepressants, aspirin, antipsychotics, anticonvulsants, or lithium, will be excluded.
- •Patients with neuropathic disorders, such as diabetic neuropathy, will be excluded.
研究者
Dr Divya Mishra
All India Institute of Medical Sciences Gorakhpur