Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

NCT02416310 | Completed

• 2 other identifiers: Xijing Hmazuike
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Keywords

TEAS; cesarean section; gastrointestinal function

Outcome Measures

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

  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 Outcomes (4)

• Electrogastrogram

  The first and second days after surgery

• 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

• 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

  One month

Study Arms (3)

TEAS group

EXPERIMENTAL

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

Device: TEAS

Sham group

SHAM COMPARATOR

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

Device: TEAS

Control group

PLACEBO COMPARATOR

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

Device: TEAS

Interventions

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.

Also known as: Transcutaneous electrical acupoint stimulation

Control group; Sham group; TEAS group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia
• Gestational age ≥38 weeks
• Provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (5)

• 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.

  PMID: 20195124 BACKGROUND

• 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.

  PMID: 11506105 BACKGROUND

• 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.

  PMID: 25146082 BACKGROUND

• 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.

  PMID: 19234827 BACKGROUND

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

  PMID: 22309587 BACKGROUND

Study Officials

• Qiang Wang

  Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 15, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 26, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08