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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Other: Wrist and ankle acupuncture

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.

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangdong, Guangzhou, China, 510600
      • The First Affiliated Hospital of Jinan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group
Intervention group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal function	The time of first exhaust and defecation were recorded.	Before discharge
drug used	The number, type, and duration of use of analgesic and antiemetic drugs when necessary	Before discharge
Quality of life situation before discharge	The quality of recovery before discharge was recorded	Before discharge
complication	The occurrence of perioperative complications was recorded	perioperative period

Collaborators and Investigators

• Sponsor: LILIAN GAO

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Anticipated): March 23, 2024
• Study Completion (Anticipated): April 15, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: LGAO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No