Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy (ASDAS)

October 14, 2019 updated by: Zhihong LU

Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial

The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current. The frequency of TEAS is set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded. Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. The adverse events were recorded.

Study Type

Interventional

Enrollment (Actual)

593

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • First Afiliated Hospital of Chongqing Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • People's Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450052
        • First Afiliated Hospital of Zhengzhou University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University
      • Xi'an, Shaanxi, China, 710005
        • Tangdu Hospital, Fourth Military Medical University
      • Xi'an, Shaanxi, China, 710022
        • First Afiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled for operation of breast cancer；
  • ASA（American Society of Anesthesiologists）I-II；
  • Aged between 18 and 65；
  • Informed consented。

Exclusion Criteria:

  • Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
  • Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
  • Certain/suspicious addiction with alcohol, analgesics or other drugs；
  • Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
  • Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
  • Suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot;
  • Severe dysfunction of liver or kidney meaning one of ALT（Alanine Transaminase）, AST（Aspartate Transaminase）, ALP（alkaline phosphatase） or TBIL（total bilirubin） is 2 times higher that normal or creatinine clearance < 30 ml/min or serum creatinine > 177umol/L;
  • Participate in the other clinical trial 3 month before the enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dual acupoint stimulation
The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), electric stimulation was given through electrode attached to the acupoints.
Device: acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
Other Names:
  • transcutaneous electrical acupoint stimulation
Experimental: single acupoint stimulation
The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.
Device: acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
Other Names:
  • transcutaneous electrical acupoint stimulation
Placebo Comparator: no stimulation
false stimulation group only attach electrodes without electric current.
Device: no stimulation
patients were only attached electrodes without electric current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of chronic pain six months after surgery
Time Frame: six months after surgery
six months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of chronic pain three months after surgery
Time Frame: three months after surgery
three months after surgery
Remifentanil consumption during the surgery
Time Frame: from start of surgery to end of surgery, at an average of 2.5 hours
from start of surgery to end of surgery, at an average of 2.5 hours
the time to the first verbal response
Time Frame: end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
the time to extubation
Time Frame: end of the anesthetics infusion to extubation,on an average of 30 minutes
end of the anesthetics infusion to extubation,on an average of 30 minutes
postoperative nausea and vomiting within 24 h after surgery
Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
respiratory depression within 24 hours after surgery
Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
patients' s satisfaction scores on analgesia within 24 hours after surgery
Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
Visual Analogue Scale scores within 24 hours after surgery
Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
demand of rescue analgesics within 24 hours after surgery
Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
pain score at 3m after surgery
Time Frame: three months after surgery
three months after surgery
pain score at 6m after surgery
Time Frame: six months after surgery
six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhihong LU

Investigators

  • Study Chair: Hailong Dong, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 23, 2018

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • XJH-A-2016-04-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD including those about primary endpoint and secondary endpoints would be available to other researchers.

IPD Sharing Time Frame

the data will become available after manuscript published, for 5 years.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on acupoint stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe