Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy

Pain Clinical Trial

— ASDAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741726
• Other study ID #: XJH-A-2016-04-12
• Status: Completed
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: October 23, 2018

Study information

• Verified date: October 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
• no stimulation
patients were only attached electrodes without electric current

Locations

Country	Name	City	State
China	First Afiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	First Afiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Tangdu Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	First Afiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	People's hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic pain six months after surgery		six months after surgery
Secondary	Incidence of chronic pain three months after surgery		three months after surgery
Secondary	Remifentanil consumption during the surgery		from start of surgery to end of surgery, at an average of 2.5 hours
Secondary	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
Secondary	the time to extubation		end of the anesthetics infusion to extubation,on an average of 30 minutes
Secondary	postoperative nausea and vomiting within 24 h after surgery		end of surgery to 24 hours after surgery,on an average of 24 hours
Secondary	respiratory depression within 24 hours after surgery		end of surgery to 24 hours after surgery,on an average of 24 hours
Secondary	patients' s satisfaction scores on analgesia within 24 hours after surgery		end of surgery to 24 hours after surgery,on an average of 24 hours
Secondary	Visual Analogue Scale scores within 24 hours after surgery		end of surgery to 24 hours after surgery,on an average of 24 hours
Secondary	demand of rescue analgesics within 24 hours after surgery		end of surgery to 24 hours after surgery,on an average of 24 hours
Secondary	pain score at 3m after surgery		three months after surgery
Secondary	pain score at 6m after surgery		six months after surgery