Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Effect and mechanism of transcutaneous electrical acupoint stimulation postoperative pain in children undergoing lower extremity orthopedic surgery under ERAS mode

Registration number：

ITMCTR2200005969

Date of Last Refreshed on：

2022-05-04

Date of Registration：

2022-05-04

Registration Status：

Prospective registration

Public title：

Effect and mechanism of transcutaneous electrical acupoint stimulation postoperative pain in children undergoing lower extremity orthopedic surgery under ERAS mode

English Acronym：

Scientific title：

Effect and mechanism of transcutaneous electrical acupoint stimulation postoperative pain in children undergoing lower extremity orthopedic surgery under ERAS mode

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200059577 ; ChiMCTR2200005969

Applicant：

Li Yajun

Study leader：

Ma Yaqun

Applicant telephone：

15082877881

Study leader's telephone：

13381138327

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1031923995@qq.com

Study leader's E-mail：

ma_yq126@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 5, Nanmencang, Dongsi Street, Dongcheng District, Beijing

Study leader's address：

No. 5, Nanmencang, Dongsi Street, Dongcheng District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Seventh Medical Center of Chinese People's Liberation Army General Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2022-18

Approved file of Ethical Committee：

Name of the ethic committee：

Ethics Committee of the seventh medical center of PLA General Hospital

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Yang Rongya

Contact Address of the ethic committee：

No. 5, Nanmencang, Dongsi Street, Dongcheng District, Beijing

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Seventh Medical Center of Chinese People's Liberation Army General Hospital

Primary sponsor's address：

No. 5, Nanmencang, Dongsi Street, Dongcheng District, Beijing

Secondary sponsor：

Country：

CHINA

Province：

Beijing

City：

Institution
hospital：

Seventh Medical Center of Chinese People's Liberation Army General Hospital

Address：

No. 5, Nanmencang, Dongsi Street, Dongcheng District, Beijing

Source(s) of funding：

no

Target disease：

Lower limb orthopedic surgery

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study aims to observe the application of transcutaneous electrical acupoint stimulation combined with general anesthesia in children, and evaluate the effect and mechanism of eras mode on postoperative pain in children, in order to find more and safer ways to prevent postoperative pain in children, which has important clinical significance.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

nclusion criteria: (1) they were clearly diagnosed by imaging and met the diagnostic criteria of orthopedic related diseases; (2) Children who plan to undergo orthopedic lower limb Orthopedics; (3) Age 3-14 years old; (4) ASA grade 1-2; (5) The parents of all children agreed and signed the informed consent form.

Exclusion criteria：

Exclusion criteria: (1) local infection near acupoints; (2) Combined with mental diseases; (3) History of chronic pain and opioid use; (4) Accompanied by serious systemic diseases; (5) Congenital heart disease and malignant tumor.

Study execute time：

From 2022-05-01

To      2023-01-01

Recruiting time：

From 2022-05-01

To      2023-01-01

Interventions：

29

Group：

control group

Sample size：

Intervention：

nothing

Intervention code：

29

Group：

experimental group

Sample size：

Intervention：

transcutaneous electrical acupoint stimulation

Intervention code：

Total sample size ： 58

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Seventh Medical Center of Chinese People's Liberation Army General Hospital

Level of the institution：

Class III class A

Outcomes：

Outcome：

Restlessness score in awakening period

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative pain score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random sequences are generated by completely randomized grouping

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

no

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

no

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above