Electrical Acupoint Stimulation for Postoperative Recovery

Not Applicable

• Conditions: Postoperative Infection; Postoperative Pneumonia; Postoperative Nausea and Vomiting; Postoperative Delirium; Deep Vein Thrombosis; Postoperative Recovery; Postoperative Complications; Postoperative Retention of Urine
• Interventions: Device: Transcutaneous Electrical Acupoint Stimulation; Device: Electroacupuncture; Device: sham Transcutaneous Electrical Acupoint Stimulation

• Registration Number: NCT03249701
• Lead Sponsor: Shandong University of Traditional Chinese Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02
• Study Start: 2018-05-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAS group	Transcutaneous Electrical Acupoint Stimulation	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.
Electroacupuncture group	Electroacupuncture	Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
sham TEAS group	sham Transcutaneous Electrical Acupoint Stimulation	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.

Primary Outcome Measures

Name	Time	Method
The postoperative recovery	7 days	Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.

Secondary Outcome Measures

Name	Time	Method
The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10	up to 7 days	Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml.
The level of inflammatory response by C-reactive protein	up to 7 days	Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.
The adverse event	7 days	Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.
Postoperative complications	7 days	Record the incidence of any postoperative complications during 7 days
The level of stress response	up to 7 days	Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml.

Trial Locations

Locations (1)

Affiliated hospital of shandong university of traditional chinese medicine; 🇨🇳 Ji'nan, Shandong, China