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Completed

NCT Number: NCT02543580

TEAS-induced Analgesia: Dual vs Single Acupoints

The purpose of this study is to evaluate the effects of transcutaneous electric acupoint stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and postoperative pain in patients undergoing radical mastectomy

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Key information

Conditions

Postoperative Acute Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged from 18 to 65 yrs
  • body mass index (BMI) of 18 to 30 kg/m2
  • elective radical mastectomy under general anesthesia

Exclusion criteria

  • contradictions to electric stimulation
  • difficulties in communication
  • histories of general anesthesia, drug or alcohol abuse or addiction
  • cardiac dysfunction or severe hypertension, confirmed hepatic dysfunction and renal impairment
  • participants recruited into other clinical trials during last three months

Treatment and study plan

transcutaneous electric acupoint stimulation

Other

electrodes are attached o the skin and electric stimulation is given

electrode attached but no stimulation

Other

electrodes are attached o the skin but no stimulation is given

Primary outcomes

  1. dose of remifentanil during anesthesia

    Time frame: from start of anesthesia to extubation, on average 2 hours

Secondary outcomes

  1. time to recall

    Time frame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average

    patient response to verbal command

  2. time to extubation

    Time frame: from end of remifentanil infusion to extubation,approximately 10 minutes on average

  3. incidence of respiratory depression during recovery

    Time frame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average

  4. incidence of nausea and vomiting during recovery

    Time frame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average

  5. visual analogue scale during recovery

    Time frame: from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average

  6. visual analogue scale at 24 hour after surgery

    Time frame: from end of surgery to 24 hours after surgery, totally 24 hours

  7. pain score at 3 months after surgery

    Time frame: from discharge from hospital to 3 months after surgery, approximately 3 months

  8. pain score at 6 months after surgery

    Time frame: from discharge from hospital to 6 months after surgery, approximately 3 months

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Transcutaneous Electrical Acupoint Stimulation Decreases Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy: Dual Acupoints Versus Single Acupoint in a Prospective Randomized Controlled Trial

Acronym: TADS

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 7, 2015
Registry last updated
Jun 7, 2018

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.

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