Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 主要终点
- The first 24 hours total analgesic consumption.
研究概览
简要总结
The aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery.
详细描述
Laparoscopic surgeries are becoming more attractive because of an early recovery . However, post laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site.
Proper pain relief is a major concern and area of focus. Pre-operatively, one of the most common questions asked by patients about the amount of pain they will experience after the surgery. Pain has been found to be one of the three most common medical causes of delayed discharge after ambulatory surgery, the other two being drowsiness and nausea and vomiting. Unfortunately prevention and treatment of postoperative pain continues to be a major challenge in postoperative care.
Good pain control after surgery is important to prevent negative outcomes such as tachycardia, hypertension, myocardial ischemia, decrease in alveolar ventilation, and poor wound healing.
Pain also can prolong hospital stay, which is particularly important in day case procedures.
The mechanism of laparoscopy induced shoulder pain is mainly derived from carbon dioxide retention within the abdomen, subsequently irritating the phrenic nerve and causing referred pain in the C4 dermatome. Moreover, carbon dioxide trapped between the liver and the right diaphragm, irritating the diaphragm, also causes upper abdominal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• female gender, age 20-45 years undergoing laparoscopic gynecological operations
- •American Society of Anesthesiologist physical status classification of I or II
排除标准
- •• Patients younger than 20 years or older than 45 years
- •History of chronic pain
- •Regular medication with analgesics, or steroids
- •Analgesic use within 24 h of surgery ,drug or alcohol abuse
- •Associated chronic diseases like diabetes mellitus, pulmonary diseases ,poor cardiac reserve,hepatorenal insufficiency.
研究组 & 干预措施
Pulmonary Recruitment Maneuver
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity
干预措施: Pulmonary Recruitment Maneuver (Combination Product)
Intraperitoneal Hydrocortisone
Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum
干预措施: Pulmonary Recruitment Maneuver (Combination Product)
control group
In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity.
结局指标
主要结局
The first 24 hours total analgesic consumption.
时间窗: 24 hours after surgery
Total amount of opioid drugs used after surgery for assessment of post operative pain
次要结局
- Length of the recovery and hospital stay (hours)(24 hours postoperative)
- Incidence of postoperative nausea ,vomiting or abdominal distension(%)(24 hours postoperative)
研究者
Mina Adolf Helmy
Principal Investigator
Cairo University