TEAS-induced Analgesia: Dual vs Single Acupoints

Not Applicable

Completed

• Conditions: Chronic Pain; Acute Pain; Postoperative
• Interventions: Other: transcutaneous electric acupoint stimulation; Other: electrode attached but no stimulation

• Registration Number: NCT02543580
• Lead Sponsor: Xijing Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-30
• Study Start: 2015-07
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single acupoint	transcutaneous electric acupoint stimulation	transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction
double acupoints	transcutaneous electric acupoint stimulation	transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction
sham electroacupuncture	electrode attached but no stimulation	electrode attached but no stimulation

Primary Outcome Measures

Name	Time	Method
dose of remifentanil during anesthesia	from start of anesthesia to extubation, on average 2 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China