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

• ClinicalTrials.gov Identifier: NCT02741726
• Recruitment Status: Completed
• First Posted: April 18, 2016
• Last Update Posted: October 16, 2019
• Sponsor: Zhihong LU
• Information provided by (Responsible Party): Zhihong LU, Air Force Military Medical University, China

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Device: acupoint stimulation; Device: no stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 593 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
• Actual Study Start Date: May 25, 2016
• Actual Primary Completion Date: October 23, 2017
• Actual Study Completion Date: October 23, 2018

Arms and Interventions

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 Name: 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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Incidence of chronic pain six months after surgery [ Time Frame: six months after surgery ]

Secondary Outcome Measures :

1. Incidence of chronic pain three months after surgery [ Time Frame: three months after surgery ]
2. Remifentanil consumption during the surgery [ Time Frame: from start of surgery to end of surgery, at an average of 2.5 hours ]
3. 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 ]
4. the time to extubation [ Time Frame: end of the anesthetics infusion to extubation,on an average of 30 minutes ]
5. 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 ]
6. respiratory depression within 24 hours after surgery [ Time Frame: end of surgery to 24 hours after surgery,on an average of 24 hours ]
7. 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 ]
8. 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 ]
9. 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 ]
10. pain score at 3m after surgery [ Time Frame: three months after surgery ]
11. pain score at 6m after surgery [ Time Frame: six months after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Chongqing

First Afiliated Hospital of Chongqing Medical University

Chongqing, Chongqing, China

China, Henan

People's hospital of Zhengzhou University

Zhengzhou, Henan, China, 450003

First Afiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

China, Shaanxi

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China, 710005

First Afiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710022

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Zhihong LU

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zhihong LU, Doctor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT02741726
• Other Study ID Numbers: XJH-A-2016-04-12
• First Posted: April 18, 2016
• Last Update Posted: October 16, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD including those about primary endpoint and secondary endpoints would be available to other researchers.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: the data will become available after manuscript published, for 5 years.