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Completed

NCT Number: NCT02416310

Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEAS

Device

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

Primary outcomes

  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

    Time frame: 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 outcomes

  1. Electrogastrogram

    Time frame: The first and second days after surgery

  2. Rate of nausea, vomiting, cramping abdominal pain, abdominal distension

    Time frame: 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

    Time frame: 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

    Time frame: One month

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TEAS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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