Clinical trial NCT05873270: Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Acupuncture Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparoscopic Sleeve Gastrectomy
Postoperative Nausea and Vomiting
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female patient undergoing sleeve gastric surgery in the weight loss center of the First Affiliated Hospital of Jinan University

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline pain at 24 hours after surgery
timeFrame: Change from Baseline pain at 24 hours after surgery
measure: Change from Baseline nausea and vomitting at 24 hours after surgery
timeFrame: Change from Baseline nausea and vomitting at 24 hours after surgery
Secondary outcomes:
measure: Gastrointestinal function
timeFrame: Before discharge
measure: drug used
timeFrame: Before discharge
measure: Quality of life situation before discharge
timeFrame: Before discharge
measure: complication
timeFrame: perioperative period
Other outcomes:
Locations:
city: Guangdong
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangzhou
Study officials:
References: