NCT02543580

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

December 30, 2014

Last Update Submit

June 5, 2018

Conditions

PostoperativeAcute PainChronic Pain

Keywords

mastectomytranscutaneous electrical acupoint stimulationacute painchronic pain

Outcome Measures

Primary Outcomes (1)

  • dose of remifentanil during anesthesia

    from start of anesthesia to extubation, on average 2 hours

Secondary Outcomes (8)

  • time to recall

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

  • time to extubation

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

  • incidence of respiratory depression during recovery

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

  • incidence of nausea and vomiting 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

  • +3 more secondary outcomes

Study Arms (3)

single acupoint

EXPERIMENTAL

transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction

Other: transcutaneous electric acupoint stimulation

double acupoints

EXPERIMENTAL

transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction

Other: transcutaneous electric acupoint stimulation

sham electroacupuncture

EXPERIMENTAL

electrode attached but no stimulation

Other: electrode attached but no stimulation

Interventions

transcutaneous electric acupoint stimulationOTHER

electrodes are attached o the skin and electric stimulation is given

double acupointssingle acupoint
electrode attached but no stimulationOTHER

electrodes are attached o the skin but no stimulation is given

sham electroacupuncture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Acute PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lize Xiong, MD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
For all patients, electrodes were placed at the bilateral PC6 and RN17 and connected to the Hwato Electric Acupuncture Treatment Instrument. No patients in the study had previous experience of undergoing transcutaneous electrical stimulation treatment. Patients were told that they might or might not feel the electrical stimulation. Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anaesthetists to the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2014

First Posted

September 7, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

CN(1)