Cesarean Section
Conditions
Keywords
TEAS, cesarean section, gastrointestinal function
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.
Interventions
DEVICETEAS
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.
Sponsors
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Electrogastrogram | The first and second days after surgery | — |
| 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 |
| 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 |
Outcome results
None listed