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Electrical Acupoint Stimulation for Postoperative Recovery (EAS)

S

Shandong University of Traditional Chinese Medicine

Status

Unknown

Conditions

Postoperative Complications
Postoperative Recovery
Postoperative Nausea and Vomiting
Deep Vein Thrombosis
Postoperative Retention of Urine
Postoperative Pneumonia
Postoperative Delirium
Postoperative Infection

Treatments

Device: Electroacupuncture
Device: sham Transcutaneous Electrical Acupoint Stimulation
Device: Transcutaneous Electrical Acupoint Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03249701
SZH-A-20170501-R2

Details and patient eligibility

About

This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.

Full description

Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.

Enrollment

90 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Agree to sign the contract
  • The patients receive total hip or knee arthroplasty
  • Epidural anesthesia administered

Exclusion criteria

  • The patients' age out of range setting
  • Forbidden to the administration of transcutaneous electrical acupoint stimulation
  • Communication disorder
  • The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.
  • The patients who attended another trial in the past three months
  • Emergency surgery

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

TEAS group
Experimental group
Description:
Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Treatment:
Device: Transcutaneous Electrical Acupoint Stimulation
Electroacupuncture group
Placebo Comparator group
Description:
Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Treatment:
Device: Electroacupuncture
sham TEAS group
Sham Comparator group
Description:
Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Treatment:
Device: sham Transcutaneous Electrical Acupoint Stimulation

Trial documents
2

Trial contacts and locations

1

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Central trial contact

zhang weiliang, MD; Su Fan, MD

Data sourced from clinicaltrials.gov

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