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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05873270
• Other study ID #: LGAO
• Status: Active, not recruiting
• Start date: March 23, 2023
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2023
• Source: First Affiliated Hospital of Jinan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: April 15, 2025
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Wrist and ankle acupuncture
Patients in the intervention arm started the wrist and ankle acupuncture treatment 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jinan University	Guangdong	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
LILIAN GAO

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline pain at 24 hours after surgery
Primary	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 nausea and vomitting at 24 hours after surgery
Secondary	Gastrointestinal function	The time of first exhaust and defecation were recorded.	Before discharge
Secondary	drug used	The number, type, and duration of use of analgesic and antiemetic drugs when necessary	Before discharge
Secondary	Quality of life situation before discharge	The quality of recovery before discharge was recorded	Before discharge
Secondary	complication	The occurrence of perioperative complications was recorded	perioperative period