Back to resultsTEAS-induced Analgesia: Dual vs Single Acupoints (TADS)
Primary Purpose
Postoperative, Acute Pain, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous electric acupoint stimulation
electrode attached but no stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative focused on measuring mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain
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
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
single acupoint
double acupoints
sham electroacupuncture
Arm Description
transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction
transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction
electrode attached but no stimulation
Outcomes
Primary Outcome Measures
dose of remifentanil during anesthesia
Secondary Outcome Measures
time to recall
patient response to verbal command
time to extubation
incidence of respiratory depression during recovery
incidence of nausea and vomiting during recovery
visual analogue scale during recovery
visual analogue scale at 24 hour after surgery
pain score at 3 months after surgery
pain score at 6 months after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02543580
Brief Title
TEAS-induced Analgesia: Dual vs Single Acupoints
Acronym
TADS
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative, Acute Pain, Chronic Pain
Keywords
mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
For all patients, electrodes were placed at the bilateral PC6 and RN17 and connected to the Hwato Electric Acupuncture Treatment Instrument. No patients in the study had previous experience of undergoing transcutaneous electrical stimulation treatment. Patients were told that they might or might not feel the electrical stimulation. Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anaesthetists to the group allocation.
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single acupoint
Arm Type
Experimental
Arm Description
transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction
Arm Title
double acupoints
Arm Type
Experimental
Arm Description
transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction
Arm Title
sham electroacupuncture
Arm Type
Experimental
Arm Description
electrode attached but no stimulation
Intervention Type
Other
Intervention Name(s)
transcutaneous electric acupoint stimulation
Intervention Description
electrodes are attached o the skin and electric stimulation is given
Intervention Type
Other
Intervention Name(s)
electrode attached but no stimulation
Intervention Description
electrodes are attached o the skin but no stimulation is given
Primary Outcome Measure Information:
Title
dose of remifentanil during anesthesia
Time Frame
from start of anesthesia to extubation, on average 2 hours
Secondary Outcome Measure Information:
Title
time to recall
Description
patient response to verbal command
Time Frame
from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
Title
time to extubation
Time Frame
from end of remifentanil infusion to extubation,approximately 10 minutes on average
Title
incidence of respiratory depression during recovery
Time Frame
from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
Title
incidence of nausea and vomiting during recovery
Time Frame
from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
Title
visual analogue scale during recovery
Time Frame
from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average
Title
visual analogue scale at 24 hour after surgery
Time Frame
from end of surgery to 24 hours after surgery, totally 24 hours
Title
pain score at 3 months after surgery
Time Frame
from discharge from hospital to 3 months after surgery, approximately 3 months
Title
pain score at 6 months after surgery
Time Frame
from discharge from hospital to 6 months after surgery, approximately 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lize Xiong, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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TEAS-induced Analgesia: Dual vs Single Acupoints
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