Outcome of Active Aspiration Versus Simple Compression to Remove Residual Gas From Abdominal Cavity in Reducing Pain After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Numerical Pain Intensity Scale (NPIS)
研究概览
简要总结
The aim of this study is to compare outcome of active aspiration versus simple compression to remove residual gas from abdominal cavity in reducing pain after laparoscopic cholecystectomy.
详细描述
INTRODUCTION: Laparoscopic cholecystectomy (LC) is superior to open cholecystectomy for a number of reasons: it causes less discomfort to the patient, reduces the length of the hospital stay, minimizes wound problems, promotes the speedy postoperative return to former activities and causes fewer postoperative pulmonary complications.[1,2] However, disturbing abdominal and shoulder pain can be observed after laparoscopic surgery. The elimination or reduction of this pain may increase patient comfort, promote a quick return to normal activity and reduce pulmonary and venous system problems.[3,4] In studies performed in the 1980s, Riedel and Semm showed radiologically that carbon dioxide (CO2 ) gas remained in the peritoneal area following abdominal laparoscopy.[5] Several studies indicate that this gas leads to irritation and shoulder pain if it remains below the diaphragm following laparoscopy.[6] However, pain after laparoscopy is multifactorial and can be associated with many issues: abdominal muscle tension in the abdominal front wall caused by pneumoperitoneum (Pp); the temperature and volume of insufflated gas; anaesthetic drugs and their postoperative effects; wound size; and the use of intraperitoneal acid during the operation.[7-8] A study aimed to evaluate the effectiveness of active gas aspiration to reduce postoperative shoulder pain in patients undergoing laparoscopy. The shoulder pain scores of the active gas aspiration group showed lower pain intensity than the simple gas evacuation group, with statistically significant results at all time points. There was no significant difference in surgical wound pain. The proportion of patients who required postoperative rescue analgesics was lower in the study than in control group (43.2% vs 67.6%, P = 0.035). There was no significant difference in adverse events until 24 h after surgery. Active gas aspiration provided a significantly superior effect on postoperative shoulder pain relief after diagnostic laparoscopy when compared to simple gas evacuation, without any adverse events. [9] In another study numerical pain intensity scale (NPIS) at the 24th h were significantly lower in Group 1 (p < 0.001). However, there were no significant differences in the NPIS scores following the 1st h and the 3rd day. No differences were found in the operation time (p > 0.05). According to the correlation analysis between the operation time and NPIS scores between the groups, in Group 1 the duration of surgery was significantly proportional to NPIS24. All patients were discharged from the hospital on the 4th postoperative day. [10] Rationale: Identifying the most effective technique for gas removal may have significant implications for patient care and healthcare costs. Furthermore, given the widespread use of laparoscopic cholecystectomy, this study may have broader implications for other laparoscopic procedures that require abdominal insufflation. So the objective of this study is to determine if there is a significant difference in postoperative pain scores between patients who receive active gas aspiration versus those who receive simple compression following laparoscopic cholecystectomy.
OBJECTIVE: The aim of this study is to compare outcome of active aspiration versus simple compression to remove residual gas from abdominal cavity in reducing pain after laparoscopic cholecystectomy.
OPERATIONAL DEFINITIONS Simple Compression: In this group, diagnostic laparoscopies commenced with a 5 mm intraumbilical vertical incision, followed by placement of the first bladeless umbilical port trocar (using 5 mm XCEL). Warm CO2 gas insufflation will create the pneumoperitoneum at a flow rate of 1-2.5 L/min; intra-abdominal pressure will be set at 12 mmHg. Patients will then placed in the Trendelenburg position (45°) and the second trocars (using 5 mm XCEL) will be placed at the suprapubic area. Chromopertubation with methylene blue will be performed, with electrocauterization of the endometriotic lesions if necessary. CO2 insufflation will be then ceased and all trocars will be opened. The surgeon will apply abdominal pressure to evacuate any residual CO2. The patient will be then placed in a neutral (horizon plane) position, the trocars will be removed and the incision closed.
Active Gas Aspiration: Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.
Post-operative Pain: Patients' postoperative pain will be evaluated using a visual analogue scale (VAS) at the 1st, 4th and 12th postoperative hours by a surgical nurse. Pain severity will be assessed from 0 (no pain) to 10 (unbearable pain intensity). Daily analgesic requirements will be calculated in terms of consumption per day (Diclofenac sodium/bulb, 75 mg/ amp). Analgesics will be administered to patients whose VAS score will be more than 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both genders.
- •Patients of age ≥ 18 years.
- •All patients presenting for elective laparoscopic cholecystectomy.
排除标准
- •Patients suffering from obstructive jaundice anamnesis.
- •Patients who had received a diagnosis of gallbladder cancer.
- •Patients whose procedures were converted to open cholecystectomy during the surgery.
- •Patients who had additional pathologies such as bronchial asthma, chronic obstructive pulmonary disease.
- •Patients refused to give consent.
结局指标
主要结局
Numerical Pain Intensity Scale (NPIS)
时间窗: 24 hours
The Numerical Pain Intensity Scale (NPIS) is a simple, self-reported tool commonly used in clinical settings to assess the intensity of a person's pain. It typically ranges from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst pain imaginable." Patients are asked to rate their pain based on their current experience, providing healthcare professionals with a clear indication of the pain's severity. This scale is useful for tracking pain changes over time, evaluating the effectiveness of treatments, and facilitating communication between patients and providers about pain management. The NPIS is valued for its ease of use and ability to provide quick, quantifiable insights into a patient's pain level.
次要结局
未报告次要终点
