Electrical Acupoint Stimulation for Postoperative Recovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.

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

Intervention / Treatment
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* Device: Transcutaneous Electrical Acupoint Stimulation
* Device: Electroacupuncture
* Device: sham Transcutaneous Electrical Acupoint Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS group<br>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. | Device: Transcutaneous Electrical Acupoint Stimulation<br>* The intervention will be administered by electrical acupoint machine, the brand is Great Wall.<br>|
| Placebo Comparator: Electroacupuncture group<br>Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure. | Device: Electroacupuncture<br>* The intervention will be administered by electrical acupoint machine, the brand is Great Wall.<br>|
| Sham Comparator: sham TEAS group<br>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. | Device: sham Transcutaneous Electrical Acupoint Stimulation<br>* The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative recovery | Record the postoperative recovery after surgery through quality of recovery-40 questionnaire. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse event | Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al. | 7 days | 
| The level of stress response | 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. | up to 7 days | 
| Postoperative complications | Record the incidence of any postoperative complications during 7 days | 7 days | 
| The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10 | 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. | up to 7 days | 
| The level of inflammatory response by C-reactive protein | Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L. | up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupoint Stimulation, postoperative recovery, Postoperative Complications, Peri-operation