TEAS-induced Analgesia: Dual vs Single Acupoints

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of transcutaneous electric acupoint stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and postoperative pain in patients undergoing radical mastectomy

Official Title
-----------------
Transcutaneous Electrical Acupoint Stimulation Decreases Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy: Dual Acupoints Versus Single Acupoint in a Prospective Randomized Controlled Trial

Conditions
-----------------
Chronic Pain, Postoperative, Acute Pain

Intervention / Treatment
-----------------
* Other: transcutaneous electric acupoint stimulation
* Other: electrode attached but no stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged from 18 to 65 yrs body mass index (BMI) of 18 to 30 kg/m2 elective radical mastectomy under general anesthesia Exclusion Criteria: contradictions to electric stimulation difficulties in communication histories of general anesthesia, drug or alcohol abuse or addiction cardiac dysfunction or severe hypertension, confirmed hepatic dysfunction and renal impairment participants recruited into other clinical trials during last three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single acupoint<br>transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction | Other: transcutaneous electric acupoint stimulation<br>* electrodes are attached o the skin and electric stimulation is given<br>|
| Experimental: double acupoints<br>transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction | Other: transcutaneous electric acupoint stimulation<br>* electrodes are attached o the skin and electric stimulation is given<br>|
| Experimental: sham electroacupuncture<br>electrode attached but no stimulation | Other: electrode attached but no stimulation<br>* electrodes are attached o the skin but no stimulation is given<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose of remifentanil during anesthesia |  | from start of anesthesia to extubation, on average 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to recall | patient response to verbal command | from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average | 
| time to extubation |  | from end of remifentanil infusion to extubation,approximately 10 minutes on average | 
| incidence of respiratory depression during recovery |  | from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average | 
| incidence of nausea and vomiting during recovery |  | from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average | 
| visual analogue scale during recovery |  | from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average | 
| visual analogue scale at 24 hour after surgery |  | from end of surgery to 24 hours after surgery, totally 24 hours | 
| pain score at 3 months after surgery |  | from discharge from hospital to 3 months after surgery, approximately 3 months | 
| pain score at 6 months after surgery |  | from discharge from hospital to 6 months after surgery, approximately 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain