TEAS: Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Sponsor
Xijing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02416310
Collaborator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi (Other)
150
3
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TEAS
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 26, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEAS group

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

Device: TEAS
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.
Other Names:
  • Transcutaneous electrical acupoint stimulation
  • Sham Comparator: Sham group

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

    Device: TEAS
    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.
    Other Names:
  • Transcutaneous electrical acupoint stimulation
  • Placebo Comparator: Control group

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

    Device: TEAS
    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.
    Other Names:
  • Transcutaneous electrical acupoint stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Electrogastrogram [The first and second days after surgery]

    2. 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

    3. length of postoperative hospital stay [Participants will be followed for the duration of hospital stay, an expected average of 5 days]

    4. Quality of life during 30 days after surgery [One month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xijing Hospital
    • Northwest Women's and Children's Hospital, Xi'an, Shaanxi

    Investigators

    • Study Chair: Qiang Wang, Xijing Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    wangqiang, professor, Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT02416310
    Other Study ID Numbers:
    • Xijing H
    • mazuike
    First Posted:
    Apr 15, 2015
    Last Update Posted:
    Aug 9, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by wangqiang, professor, Xijing Hospital

    Study Results

    No Results Posted as of Aug 9, 2017