Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Incidence of vomiting in the early 8 hours after surgery.
研究概览
简要总结
This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.
详细描述
Obesity and its associated disorders have significant implications for health, resulting in heightened productivity loss and reduced life expectancy while also negatively impacting the quality of life of patients. Surgical intervention is the most effective way to achieve sustainable weight loss in patients with obesity and to alleviate the associated comorbidities. Despite the current availability of minimally invasive bariatric surgical treatments, postoperative pain remains a significant issue. Vagal and sympathetic afferent signals originating from the gastrointestinal system stimulate the vomiting center, causing nausea and vomiting. Paragastric autonomic neural blockade (PANB) is a new method performed by injecting local anesthetic material into three to four separate points along the border between the lesser omentum and the stomach (from the esophagogastric junction to the distal antrum), the hepatoduodenal ligament, and the area covering the left gastric artery. This procedure aims to prevent visceral pain and symptoms of nausea and vomiting. Ondansetron is a serotonin receptor (5-HT3) antagonist used commonly to manage postoperative nausea and vomiting (PONV) through intravenous (IV) injection. It also has a local anesthetic effect and many studies used it as adjuvant in various regional anesthetic techniques. In this study, investigators will compare the combined antiemetic analgesic effects of IV and perineural (adjuvant to the local anesthetic bupivacaine in PANB) ondansetron. The investigators hypothesized that perineural administration of ondansetron will be non-inferior to the IV route regarding prophylaxis against PONV, and will provide superior postoperative analgesic effects by its local anesthetic enhancing action.
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
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex
- •American Society Anesthesiologists physical (ASA) status II-III
- •age between 18-65 years old
- •Body mass index (BMI) >35 kg/m2 with comorbidity or > 40 kg/m2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..
排除标准
- •Allergy to experimental drugs.
- •Known to have long QT, previous history of postoperative nausea and vomiting
- •Abuse of alcohol, analgesia, or sedative antidepressant drugs
- •Chronic pain disorders
- •History of previous upper gastrointestinal system surgery, those with surgery-related complications during or after surgery.
- •Liver or kidney failure
- •Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy
- •Anesthetic complications that may alter the postoperative management protocol.
研究组 & 干预措施
Perineural ondansetron group
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
干预措施: Perineural ondansetron (Drug)
Intravenous ondansetron group
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.
干预措施: Intravenous ondansetron (Drug)
结局指标
主要结局
Incidence of vomiting in the early 8 hours after surgery.
时间窗: 8 hours after surgery.
Any attack of vomiting will be recorded for all patients.
Degree of postoperative pain at 1 hour after surgery as measured by the numerical rating scale pain score.
时间窗: 1 hour after surgery.
Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain.
次要结局
- Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery.(24 hours after surgery.)
- Number of rescue anti-emetic doses in the first postoperative day.(24 hours after surgery.)
- Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery.(24 hours after surgery.)
- Time to first rescue opioid analgesic.(24 hours after surgery.)
- Total opioid dose in the first day after surgery.(24 hours after surgery.)
- Patient satisfaction(24 hours after surgery.)
研究者
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine
Tanta University
