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Trial registered on ANZCTR


Registration number
ACTRN12615000496516
Ethics application status
Approved
Date submitted
6/02/2015
Date registered
19/05/2015
Date last updated
22/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does transcutaneous electrical acupoint stimulation alleviate remifentanil-induced hyperalgesia in patients undergoing thyroidectomy: a randomized controlled trial
Scientific title
Does transcutaneous electrical acupoint stimulation alleviate remifentanil-induced hyperalgesia in patients undergoing thyroidectomy: a randomized controlled trial
Secondary ID [1] 286116 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hyperalgesia 294889 0
Condition category
Condition code
Anaesthesiology 294432 294432 0 0
Anaesthetics
Neurological 295134 295134 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the TEAS group were performed TEAS for 30 min before the induction of anesthesia in the holding area. TEAS was applied to two pairs of acupoints: bilateral Hegu (LI4) and Neiguan (PC6).The acupoints were stimulated with a dense-disperse frequency of 2/10 Hz and an intensity of 6–9 mA for 30 min, using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).
Intervention code [1] 291114 0
Treatment: Devices
Comparator / control treatment
In the sham group, the patients had the electrodes applied, but received no stimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 294229 0
The primary outcome was mechanical pain threshold.
Mechanical pain threshold on the nondominant forearm and peri-incisional areas using electronic Von Frey Anesthesiometer (IITC Inc., Life Science Instruments, Woodland Hills, CA, USA ).
Timepoint [1] 294229 0
Mechanical pain threshold was assessed before surgery and postoperatively 0.5, 1, 2, 4 and 24 h.
Secondary outcome [1] 312837 0
Postoperative pain intensity was rated with Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable.
Timepoint [1] 312837 0
Postoperative pain intensity was rated at postoperative hours 0.5, 1, 2, 4 and 24.
Secondary outcome [2] 314299 0
The incidence of postoperative nausea and vomiting (PONV)
Timepoint [2] 314299 0
A patient will be considered to suffer from PONV if nausea or vomiting is documented in 24 h after surgery.
Secondary outcome [3] 314304 0
The incidence of dizziness
Timepoint [3] 314304 0
The incidence of dizziness was evaluated in 24 h postoperatively.

Eligibility
Key inclusion criteria
We enrolled 60 ASA I-II consecutive female subjects, aged 18 to 60 years, who scheduled for elective thyroidectomy under general anesthesia.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Potentially difficult airway, a history of chronic pain, drug or alcohol abuse, intake of any analgesic drug within 48 h before surgery, mental disorder, bradycadia, diabetes, pregnancy, and previous experience with acupuncture treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group assignments were concealed in sealed envelopes and assigned to either the TEAS group or the sham group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was performed in a 1:1 ratio according to a computer-generated list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample size calculation for the two-tailed testing of the TEAS superiority hypothesis was based on the peri-incisional mechanical pain thresholds. A 30% difference represents a clinically relevant significance based on a previous study. The estimated sample size was 28 patients per group with a power of 80% at a a level of 0.05. Thus, the sample size was set at 30 patients per group allowing for incomplete follow-up or dropout.
Statistical analysis was performed using SPSS version 18.0 (SPSS Inc., Chicago, IL, USA). Parametric data were reported as mean (standard deviation) and analyzed with the independent t-test, and nonparametric data were reported as median (interquartile range) and analyzed using the Mann–Whitney U-test. Categorical variables were reported as the number of patients (%) and evaluated using the x2 or Fisher’s exact test when appropriate. A P-value < 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2015
Actual
5/03/2015
Date of last participant enrolment
Anticipated
31/07/2016
Actual
27/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6631 0
China
State/province [1] 6631 0
Fujian

Funding & Sponsors
Funding source category [1] 290694 0
Government body
Name [1] 290694 0
Social Development of Key Projects in Fujian Province (2012Y0012)
Country [1] 290694 0
China
Primary sponsor type
Individual
Name
Yusheng Yao, Department of Anesthesiology,Fujian Provincial Hospital
Address
Department of Anesthesiology,Fujian Provincial Hospital, No. 134, Dongjie, Fuzhou 350001
Country
China
Secondary sponsor category [1] 289387 0
Individual
Name [1] 289387 0
Yanqing Chen, Department of Anesthesiology,Fujian Provincial Hospital
Address [1] 289387 0
Department of Anesthesiology,Fujian Provincial Hospital, No. 134, Dongjie, Fuzhou 350001
Country [1] 289387 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292332 0
the Institutional Review Board of Fujian Provincial Hospital
Ethics committee address [1] 292332 0
No.134, Dongjie, Fuzhou 350001
Ethics committee country [1] 292332 0
China
Date submitted for ethics approval [1] 292332 0
02/01/2015
Approval date [1] 292332 0
19/01/2015
Ethics approval number [1] 292332 0
K2015-01-007

Summary
Brief summary
Transcutaneous electric acupoint stimulation (TEAS), a non-invasive technique, can be applied by personnel with minimal training. Several clinical trials have demonstrated that TEAS has the potential to reduce postoperative pain and perioperative analgesic consumption. However, the effects of TEAS on remifentanil induced hyperalgesia remains unknown. Therefore, we designed this prospective, randomized, double-blind study to verify the hypothesis TEAS can alleviate remifentanil induced hyperalgesia in patients undergoing thyroidectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54702 0
Dr Yusheng Yao, Department of Anesthesiology, Fujian Provincial Hospital
Address 54702 0
Department of Anesthesiology, Fujian Provincial Hospital, No.134, Dongjie, Fuzhou 350001
Country 54702 0
China
Phone 54702 0
+86-13559939629
Fax 54702 0
Email 54702 0
[email protected]
Contact person for public queries
Name 54703 0
Dr Yusheng Yao,Department of Anesthesiology, Fujian Provincial Hospital
Address 54703 0
Department of Anesthesiology, Fujian Provincial Hospital, No.134, Dongjie, Fuzhou 350001
Country 54703 0
China
Phone 54703 0
+86-13559939629
Fax 54703 0
Email 54703 0
[email protected]
Contact person for scientific queries
Name 54704 0
Dr Yusheng Yao, Department of Anesthesiology, Fujian Provincial Hospital
Address 54704 0
Department of Anesthesiology, Fujian Provincial Hospital, No.134, Dongjie, Fuzhou 350001
Country 54704 0
China
Phone 54704 0
+86-13559939629
Fax 54704 0
Email 54704 0
[email protected]

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