TEAS-induced Analgesia: Dual vs Single Acupoints

Chronic Pain Clinical Trial

— TADS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543580
• Other study ID #: xijingmazui24
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2018
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Postoperative

Intervention

Other:
• transcutaneous electric acupoint stimulation
electrodes are attached o the skin and electric stimulation is given
• electrode attached but no stimulation
electrodes are attached o the skin but no stimulation is given

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose of remifentanil during anesthesia		from start of anesthesia to extubation, on average 2 hours
Secondary	time to recall	patient response to verbal command	from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
Secondary	time to extubation		from end of remifentanil infusion to extubation,approximately 10 minutes on average
Secondary	incidence of respiratory depression during recovery		from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
Secondary	incidence of nausea and vomiting during recovery		from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
Secondary	visual analogue scale during recovery		from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average
Secondary	visual analogue scale at 24 hour after surgery		from end of surgery to 24 hours after surgery, totally 24 hours
Secondary	pain score at 3 months after surgery		from discharge from hospital to 3 months after surgery, approximately 3 months
Secondary	pain score at 6 months after surgery		from discharge from hospital to 6 months after surgery, approximately 3 months