Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy

NCT02741726 | Completed

• 1 other identifier: XJH-A-2016-04-12
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic pain six months after surgery

  six months after surgery

Secondary Outcomes (11)

• Incidence of chronic pain three months after surgery

  three months after surgery

• Remifentanil consumption during the surgery

  from start of surgery to end of surgery, at an average of 2.5 hours

• the time to the first verbal response

  end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes

• the time to extubation

  end of the anesthetics infusion to extubation,on an average of 30 minutes

• postoperative nausea and vomiting within 24 h after surgery

  end of surgery to 24 hours after surgery,on an average of 24 hours

Study Arms (3)

dual acupoint stimulation

EXPERIMENTAL

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

single acupoint stimulation

EXPERIMENTAL

The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.

Device: acupoint stimulation

no stimulation

PLACEBO COMPARATOR

false stimulation group only attach electrodes without electric current.

Device: no stimulation

Interventions

acupoint stimulation DEVICE

Electric stimulation was given through electrode attached to acupoints

Also known as: transcutaneous electrical acupoint stimulation

dual acupoint stimulation; single acupoint stimulation

no stimulation DEVICE

patients were only attached electrodes without electric current

no stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (6)

First Afiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

People's hospital of Zhengzhou University

Zhengzhou, Henan, 450003, China

Location

First Afiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710005, China

Location

First Afiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710022, China

Location

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Lu Z, Wang Q, Sun X, Zhang W, Min S, Zhang J, Zhao W, Jiang J, Wang Y, Zhu Y, Zheng L, Wang Y, Guo Y, Zhang L, Wang L, Lei C, Liu T, Yang X, Zhang J, Li C, Zhang N, Dong H, Xiong L. Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial. J Clin Anesth. 2021 Nov;74:110453. doi: 10.1016/j.jclinane.2021.110453. Epub 2021 Jul 13.

  PMID: 34271271 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hailong Dong

  Air Force Military Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: May 25, 2016
• Primary Completion: October 23, 2017
• Study Completion: October 23, 2018
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: the data will become available after manuscript published, for 5 years.

Locations

CN (6)