Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Conditions
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Cesarean Section

Intervention / Treatment
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* Device: TEAS


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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS group<br>TEAS are performed by a specific investigator on the specially acupoint. | Device: TEAS<br>* 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.<br>* Other names: Transcutaneous electrical acupoint stimulation;|
| Sham Comparator: Sham group<br>TEAS are performed by a specific investigator on the non-acupoint. | Device: TEAS<br>* 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.<br>* Other names: Transcutaneous electrical acupoint stimulation;|
| Placebo Comparator: Control group<br>Only place cutted electrodes but do not give any electrical stimulation. | Device: TEAS<br>* 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.<br>* Other names: Transcutaneous electrical acupoint stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrogastrogram |  | 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 | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| 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 | This is a scale to evaluate the quality of life after surgery | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEAS, cesarean section, gastrointestinal function