Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Xijing Hospital150 enrolled

Overview

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.

Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications. Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Cesarean Section

Interventions

TEASDEVICE

According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves. Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia 2. Gestational age ≥38 weeks 3. Provide written informed consent Exclusion Criteria: 1. ASA status≥Ⅲ 2. Patients undergoing surgery within 12 h of admission to hospital 3. Patients with fetal anomaly，medical or obstetric complications such as Diabetes mellitus、Hypertension、Obesity(BMW≥35) 4. Patients suffered from drug addiction or impaired mental state 5. Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease. 6. Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints 7. Patients with experience of transcutaneous electrical stimulation treatment 8. Participate in the other clinical trial 3 months before the enrollment 9. Not suitable to participate in this experiment

Outcomes

Primary Outcomes

Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet

This is a composite outcome to estimate the gastrointestinal motility function

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcomes

Electrogastrogram

Time frame: The first and second days after surgery

Rate of nausea, vomiting, cramping abdominal pain, abdominal distension

This is a composite outcome to estimate the complication of digestive system

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

length of postoperative hospital stay

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Quality of life during 30 days after surgery

This is a scale to evaluate the quality of life after surgery

Time frame: One month

Data from ClinicalTrials.gov

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