Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

Cesarean Section Clinical Trial

— TEAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416310
• Other study ID #: Xijing H
• Secondary ID: mazuike
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: August 7, 2017
• Start date: September 1, 2015
• Est. completion date: March 26, 2016

Study information

• Verified date: August 2017
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 26, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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=?

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Northwest Women's and Children's Hospital

References & Publications (5)

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. Review. — View Citation

Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	This is a composite outcome to estimate the gastrointestinal motility function	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Electrogastrogram		The first and second days after surgery
Secondary	Rate of nausea, vomiting, cramping abdominal pain, abdominal distension	This is a composite outcome to estimate the complication of digestive system	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	length of postoperative hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Quality of life during 30 days after surgery	This is a scale to evaluate the quality of life after surgery	One month