Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section

• Registration Number: NCT02416310
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Study Start: 2015-09-01
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Participants will be followed for the duration of hospital stay, an expected average of 5 days	This is a composite outcome to estimate the gastrointestinal motility function

Secondary Outcome Measures

Name	Time	Method
Rate of nausea, vomiting, cramping abdominal pain, abdominal distension	Participants will be followed for the duration of hospital stay, an expected average of 5 days	This is a composite outcome to estimate the complication of digestive system
Electrogastrogram	The first and second days after surgery
length of postoperative hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Quality of life during 30 days after surgery	One month	This is a scale to evaluate the quality of life after surgery