Skip to main content
OpenTrials
Completed

NCT Number: NCT02741726

Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

First Afiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupoint stimulation

Device

Electric stimulation was given through electrode attached to acupoints

Other names: transcutaneous electrical acupoint stimulation

No stimulation

Device

patients were only attached electrodes without electric current

Primary outcomes

  1. Incidence of chronic pain six months after surgery

    Time frame: six months after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: ASDAS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 18, 2016
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.