PostoperativeTADSNCT02543580
TEAS-induced Analgesia: Dual vs Single Acupoints
A study testing transcutaneous electric acupoint stimulation and electrode attached but no stimulation in people with Postoperative and Acute Pain, run by Xijing Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative, Acute Pain, Chronic Pain
- What is being tested?
- transcutaneous electric acupoint stimulation and electrode attached but no stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged from 18 to 65 yrs
- body mass index (BMI) of 18 to 30 kg/m2
- elective radical mastectomy under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Postoperative, Acute Pain, Chronic Pain
- Being tested
- transcutaneous electric acupoint stimulation, electrode attached but no stimulation
- Keywords
- mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electric acupoint stimulationOther
electrodes are attached o the skin and electric stimulation is given
electrode attached but no stimulationOther
electrodes are attached o the skin but no stimulation is given
| Study group | Role | What they receive |
|---|---|---|
| single acupoint | Experimental | transcutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction Receives: Other: transcutaneous electric acupoint stimulation |
| double acupoints | Experimental | transcutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction Receives: Other: transcutaneous electric acupoint stimulation |
| sham electroacupuncture | Experimental | electrode attached but no stimulation Receives: Other: electrode attached but no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose of remifentanil during anesthesia
Measured: from start of anesthesia to extubation, on average 2 hours
Secondary outcomes (8)
time to recall
patient response to verbal command
Measured: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
time to extubation
Measured: from end of remifentanil infusion to extubation,approximately 10 minutes on average
incidence of respiratory depression during recovery
Measured: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
incidence of nausea and vomiting during recovery
Measured: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
visual analogue scale during recovery
Measured: from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average
visual analogue scale at 24 hour after surgery
Measured: from end of surgery to 24 hours after surgery, totally 24 hours
pain score at 3 months after surgery
Measured: from discharge from hospital to 3 months after surgery, approximately 3 months
pain score at 6 months after surgery
Measured: from discharge from hospital to 6 months after surgery, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostoperativeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangqiang, Xijing Hospital
- Investigators
- Lize Xiong, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543580
- Sponsor's protocol ID
- xijingmazui24
- Acronym
- TADS
- Status last verified
- Jun 2018
- First submitted
- 30 Dec 2014
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02543580
- Acronym / sponsor ID
- TADS / xijingmazui24
- Conditions
- Postoperative, Acute Pain, Chronic Pain
- Keywords
- mastectomy, transcutaneous electrical acupoint stimulation, acute pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single acupoint | Experimental | Other: transcutaneous electric acupoint stimulationtranscutaneous electric acupoint stimulation is given at bilateral neiguan or 30min before anesthesia induction |
| double acupoints | Experimental | Other: transcutaneous electric acupoint stimulationtranscutaneous electric acupoint stimulation is given at Danzhong and bilateral neiguan or 30min before anesthesia induction |
| sham electroacupuncture | Experimental | Other: electrode attached but no stimulationelectrode attached but no stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged from 18 to 65 yrs
- body mass index (BMI) of 18 to 30 kg/m2
- elective radical mastectomy under general anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electric acupoint stimulationelectrodes are attached o the skin and electric stimulation is given | Other | double acupoints, single acupoint |
| electrode attached but no stimulationelectrodes are attached o the skin but no stimulation is given | Other | sham electroacupuncture |
Primary outcome
dose of remifentanil during anesthesia
Time frame: from start of anesthesia to extubation, on average 2 hours
8 secondary outcomes
time to recall
Time frame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
time to extubation
Time frame: from end of remifentanil infusion to extubation,approximately 10 minutes on average
incidence of respiratory depression during recovery
Time frame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
incidence of nausea and vomiting during recovery
Time frame: from extubation to discharge from post anesthesia care unit, approximately 40 minutes on average
visual analogue scale during recovery
Time frame: from arriving to discharge from post anesthesia care unit, approximately 30 minutes on average
visual analogue scale at 24 hour after surgery
Time frame: from end of surgery to 24 hours after surgery, totally 24 hours
pain score at 3 months after surgery
Time frame: from discharge from hospital to 3 months after surgery, approximately 3 months
pain score at 6 months after surgery
Time frame: from discharge from hospital to 6 months after surgery, approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lize Xiong, MD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electric acupoint stimulation and electrode attached but no stimulation in people with Postoperative and Acute Pain, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose of remifentanil during anesthesia (time frame: from start of anesthesia to extubation, on average 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.