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

NCT05873270 | Unknown DMC

• 1 other identifier: LGAO
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Sleeve Gastrectomy; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Gastrointestinal function

  Before discharge

• drug used

  Before discharge

• Quality of life situation before discharge

  Before discharge

• complication

  perioperative period

Study Arms (2)

control group

Intervention group

Other: Wrist and ankle acupuncture

Interventions

Wrist and ankle acupuncture OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patient undergoing sleeve gastric surgery in the weight loss center of the First Affiliated Hospital of Jinan University
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LILIAN GAO: lead

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangdong, Guangzhou, 510600, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 24, 2023
• Study Start: March 23, 2023
• Primary Completion: March 23, 2024
• Study Completion: April 15, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (1)