Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section (TEAS)

Effect of Perioperative 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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Device: TEAS

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrogastrogram		The first and second days after surgery
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
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	This is a scale to evaluate the quality of life after surgery	One month

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
• Investigators: Study Chair: Qiang Wang, Xijing Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 26, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; TEAS; gastrointestinal function
• Other Study ID Numbers: Xijing H (XijingH); mazuike (Other Identifier: Xijing Hospital)