TEAS-induced Analgesia: Dual vs Single Acupoints

NCT ID: NCT02543580

Last Updated: 2018-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Acute Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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single acupoint

transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction

Group Type EXPERIMENTAL

transcutaneous electric acupoint stimulation

Intervention Type OTHER

electrodes are attached o the skin and electric stimulation is given

double acupoints

transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction

Group Type EXPERIMENTAL

transcutaneous electric acupoint stimulation

Intervention Type OTHER

electrodes are attached o the skin and electric stimulation is given

sham electroacupuncture

electrode attached but no stimulation

Group Type EXPERIMENTAL

electrode attached but no stimulation

Intervention Type OTHER

electrodes are attached o the skin but no stimulation is given

Interventions

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transcutaneous electric acupoint stimulation

electrodes are attached o the skin and electric stimulation is given

Intervention Type OTHER

electrode attached but no stimulation

electrodes are attached o the skin but no stimulation is given

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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wangqiang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lize Xiong, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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xijingmazui24

Identifier Type: -

Identifier Source: org_study_id

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