Clinical trial NCT02416310: Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
Official title: Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: TEAS
cesarean section
gastrointestinal function
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
First posted: 2015-04-15
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Electrogastrogram
timeFrame: The first and second days after surgery
measure: Rate of nausea, vomiting, cramping abdominal pain, abdominal distension
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: length of postoperative hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Quality of life during 30 days after surgery
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Qiang Wang
role: STUDY_CHAIR
References:
citation: Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
citation: Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
citation: Cheong KB, Zhang JP, Huang Y. The effectiveness of acupuncture in postoperative gastroparesis syndrome--a systematic review and meta-analysis. Complement Ther Med. 2014 Aug;22(4):767-86. doi: 10.1016/j.ctim.2014.05.002. Epub 2014 May 12.
citation: Oshima M, Aoyama K, Warabi K, Akazawa T, Inada E. Electrogastrography during and after cesarean delivery. J Anesth. 2009;23(1):75-9. doi: 10.1007/s00540-008-0692-5. Epub 2009 Feb 22.
citation: Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007.