Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Needle Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from Baseline nausea and vomitting at 24 hours after surgery
研究概览
简要总结
PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance, wound splitting, incisional hernia, and even residual gastric leakage and aspiration pneumonia, resulting in prolonged hospital stay and increased medical costs. Wrist and ankle acupuncture is a special kind of acupuncture therapy. Through subcutaneous stimulation, the electrical signal is fed back along the nerve fiber into the cerebral cortex, without dialectical treatment, and only needs the appropriate symptoms and signs of the patient. Although only in the wrist and ankle, it can solve a series of problems in the whole body, especially nausea, vomiting and pain symptoms.
详细描述
Patients scheduled for female sleeve gastric surgery were selected, and the trial was designed into the control group (n=33) and the intervention group (33). The intervention group was based on the control group, combined with the intervention of the wrist and ankle acupuncture, namely, the wrist and ankle acupuncture treatment was started 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In accordance with the Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 edition);
- •ASA grades II-III; Age: 18-65 years old;
- •Denial of smoking history;
- •Denied any history of motion sickness or PONV;
- •Female patients proposed to undergo laparoscopic sleeve gastrectomy under elective general anesthesia;
- •Voluntary attended and signed informed consent.
排除标准
- •With known drug allergies related to this study;
- •Severe heart, respiratory, renal or liver diseases, and coagulation disorders;
- •Psychiatric or neurological disorders;
- •difficulties in communication;
- •Premedication or premedical conditions limits target assessment, including use of antiemetics, opioids or corticosteroids (excluding anesthetic medication);
- •Gastroesophageal reflux (GRED), clinically assessed as severe GRED or preoperative gastroscopy indicating grade B of oesophagitis or above;
- •Patients undergoing combined cholecystectomy and gynecological surgery during the operation.
结局指标
主要结局
Change from Baseline nausea and vomitting at 24 hours after surgery
时间窗: Change from Baseline nausea and vomitting at 24 hours after surgery
PONV was scored using the Visual Nausea analog core (Visual Analog Scale of Nausea, VASN).0 represents no significant nausea and vomiting in the past period; 1-3 represents mild PONV does not affect sleep; 4-6 represents moderate PONV slightly affects sleep; and 7-10 represents severe PONV causes failed to sleep. The simplified PONV impact scale was used while performing the VASN score. The assessment of PONV severity was performed to ensure the objectivity of the outcome measures evaluation. The simplified questionnaire consisted of 2 questions, each with the corresponding score, scoring 5 points defined as clinically significant PONV
Change from Baseline pain at 24 hours after surgery
时间窗: Change from Baseline pain at 24 hours after surgery
Using Visual Analogue Scale of Pain (VASP), a score 0 represents no significant pain in the past time period; a score 1-3 represents mild pain that does not affect sleep; a score 4-6 means moderate pain that slightly affects sleep; and a score 7-10 represents severe pain leading to poor sleep or painful awakening from sleep
次要结局
- Quality of life situation before discharge(Before discharge)
- drug used(Before discharge)
- Gastrointestinal function(Before discharge)
- complication(perioperative period)
研究者
LILIAN GAO
nurse
First Affiliated Hospital of Jinan University