Intraperitoneal Instillation of Ketamine Versus Fentanyl as Adjuvants to Bupivacaine for Postoperative Pain Control in Laparoscopic Cholecystectomy _a Double-blinded Randomized Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Time of first analgesic request.
研究概览
简要总结
Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder stones; however, the origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual carbon dioxide irritating the diaphragm. Intraperitoneal administration of local anesthetics has been shown to improve postoperative pain control and reduce the need for systemic analgesics. The addition of adjuvant agents such as fentanyl or ketamine may further enhance analgesic efficacy. This randomized double-blind study aims to compare the effectiveness of intraperitoneal ketamine versus fentanyl as adjuvants to bupivacaine in reducing postoperative pain and analgesic requirements following laparoscopic cholecystectomy.
详细描述
Laparoscopic cholecystectomy (LC) is widely recognized as the gold standard for the treatment of gallbladder stones due to its significant advantages over the conventional open surgical approach. These benefits include faster postoperative recovery, reduced surgical morbidity, shorter hospital stay, and decreased postoperative pain. Despite these advantages, postoperative pain remains a major concern and is considered one of the primary factors affecting patient comfort and delaying discharge following surgery. Abdominal pain is usually most pronounced during the first 24 hours after the procedure, while shoulder pain commonly develops on the second postoperative day as a consequence of diaphragmatic irritation caused by residual carbon dioxide. Because postoperative pain after laparoscopic surgery is multifactorial in origin, a multimodal analgesic approach is widely recommended . Various strategies have been employed to improve pain control, including the use of local anesthetics administered alone or in combination with intraperitoneal opioid analgesics. Intraperitoneal (I.P.) administration of local anesthetics has become a popular and effective technique for postoperative pain management, as it can reduce the need for systemic analgesics and minimize the adverse effects associated with nonsteroidal anti-inflammatory drugs and opioids. This approach was first investigated in gynecological laparoscopic procedures and has since been extensively studied in patients undergoing LC. Several studies have demonstrated that the addition of adjuvants such as fentanyl, a potent synthetic opioid, and ketamine, an N-methyl-D-aspartate receptor antagonist, may enhance and prolong postoperative analgesia. Consequently, intraperitoneal instillation of local anesthetics with adjuvant agents represents a simple, safe, and effective method for improving postoperative pain control following LC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
An independent anesthesiologist randomly divided the patients into 42 groups of patients each using computer-generated random numbers fentanyl group and ketamine group (Group F and Group K). We discreetly placed the randomization results in envelopes until the end of the study. Both ketamine and fentanyl are colorless liquids, and they were digitally encoded so that the researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age 20-50 years
- •Patients of either gender
- •Patients planned to undergo elective LC.
- •Patients have I-II of the American Society of Anaesthesiologists (ASA)
排除标准
- •Patient's refusal.
- •body mass index (BMI) ≥40 kg/m
- •History of hypersensitivity to the drugs being evaluated
- •Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
- •chronic use of opioids and opioid addiction
- •Patients with acute cholecystitis or converted to open surgery.
- •Carcinoma of gall bladder
- •Pregnant female
- •Bleeding disorders
结局指标
主要结局
Time of first analgesic request.
时间窗: 24 hours
The primary outcome of the study is comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus Ketamine as adjuvants to bupivacaine in patients undergoing laparoscopic cholecystectomy
次要结局
- Total analgesia consumption postoperatively.(24 hours)
- Postoperative Numeric Rating Scale of pain(24 hours postoperatively.)
研究者
Tarek Mohamed Essa Tohamy
Resident
Assiut University