Efficacy and Safety of Paragastric Neural Block in Controlling Pain, Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy; Prospective Randomized Controlled Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Surgical treatment is the most effective way to achieve effective and sustainable weight loss in patients with obesity and to improve the comorbidities caused by it.
Although minimally invasive bariatric surgical procedures are applied today, postoperative pain is one of the most basic problems. Opioid-derived drugs used for pain control cause respiratory depression and constipation. Enhanced Recovery After Surgery (ERAS) protocols recommend reducing opioid use after bariatric surgery to help patients have a healthier postoperative period.
Different methods such as transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are used to reduce the postoperative opioid dose and for effective pain control. While these methods are effective in controlling somatic pain, they have no effect on visceral pain.
It has been shown that patients' pain and opioid consumption decrease especially after celiac plexus block. Vagal and sympathetic afferent stimuli from the gastrointestinal tract, on the other hand, stimulate the vomiting center and cause nausea and vomiting. Paragastric neural block is a new method performed by injecting local anesthetic into the posterosuperior paragastric area in the area covering the left gastric artery by revealing the esophagogastric junction, proximal stomach, middle of the stomach, distal antrum, hepatoduodenal ligament and stomach posterior along the border of the lesser omentum. In this way, it is aimed to prevent both visceral pain and the symptoms of nausea and vomiting.
In our study, the investigators aimed to evaluate the efficacy and safety of paragastric nerve block applied during laparoscopic sleeve gastrectomy by comparing it with the control group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization was performed by a general surgeon who would not be present during the block procedure. Patients were numbered sequentially according to the randomization scheme. Patient numbers were recorded in the follow-up files. Evaluation of the postoperative results was done by a general surgeon who was unaware of the group distributions. Since both the patients and the general surgeon who will make the evaluation did not know whether the block procedure was applied or not, the study was performed as double-blind.
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
- •Body mass index of over 35 and an obesity-related comorbidity,
- •Body mass index of over 40,
- •Patients who underwent laparoscopic sleeve gastrectomy,
- •ASA risk score of 2-3,
- •Agreed to be included in the study.
排除标准
- •Chronic pain disorder or using gabapentin,
- •Opioid addicts,
- •Using anticoagulant drugs,
- •History of previous upper gastrointestinal system surgery,
- •Surgical complications during or after surgery,
- •Hepatic or renal failure,
- •Moderate or severe cardiovascular or respiratory disease,
- •Allergy to the local anesthetic agent to be applied for the block,
- •Limited cooperation,
- •More than one surgical intervention in the same session,
- •Allergy to the drugs to be used in the postoperative treatment protocol.
结局指标
主要结局
Postoperative pain
时间窗: In first 24 hours
The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).
Postoperative nause and vomiting
时间窗: In first 24 hours
The investigators used Post operative nause and vomiting impact scale. Minimum value 0, maximum values 6. Total score \>4 defines clinically important postoperative nause and vomiting.
次要结局
- First Rescue analgesia(In first 24 hours)
- Pulse 10 minutes after the block(10 minutes after the block)
- Sistolic blood pressure 10 minutes after the block(10 minutes after the block)
- Diastolic blood pressure before the block(at block moment)
- Complication at the block site(Through operation, an avarage of 1 hour)
- Time to second rescue analgesia(In first 24 hours)
- Operation time(Through operation completion, an avarage of 1 hour)
- Sistolic blood pressure before the block(at block moment)
- Diastolic blood pressure 10 minutes after the block(10 minutes after the block)
- Pulse before block(at block moment)
- Second Rescue analgesia(In first 24 hours)
- Rescue antiemetic(In first 24 hours)
- Patient satisfaction(In first 72 hours)
- Time to rescue antiemetic(In first 24 hours)
- Time to first rescue analgesia(In first 24 hours)
- First mobilization time(In first 24 hours)