Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section (TEAS)

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Cesarean Section

Treatments: Device: TEAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02416310

Xijing H (Registry Identifier)

mazuike (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

TEAS group

Experimental group

Description:

TEAS are performed by a specific investigator on the specially acupoint.

Treatment:

Device: TEAS

Sham group

Sham Comparator group

Description:

TEAS are performed by a specific investigator on the non-acupoint.

Treatment:

Device: TEAS

Control group

Placebo Comparator group

Description:

Only place cutted electrodes but do not give any electrical stimulation.

Treatment:

Device: TEAS