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Electroacupuncture for acute postoperative pain after video-assisted thoracoscopic surgery: a randomized controlled trial

Registration number：

ITMCTR2024000170

Date of Last Refreshed on：

2024-08-05

Date of Registration：

2024-08-05

Registration Status：

Prospective registration

Public title：

Electroacupuncture for acute postoperative pain after video-assisted thoracoscopic surgery: a randomized controlled trial

English Acronym：

Scientific title：

Electroacupuncture for acute postoperative pain after video-assisted thoracoscopic surgery: a randomized controlled trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Dan-Tong Zhang

Study leader：

Cun-Zhi Liu

Applicant telephone：

+86 186 2690 5699

Study leader's telephone：

+86 10 5391 2201

Applicant Fax：

Study leader's fax：

Applicant E-mail：

z_dant@163.com

Study leader's E-mail：

lcz_tg@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

11 North Third Ring Road East, Chaoyang District Beijing

Study leader's address：

11 North Third Ring Road East, Chaoyang District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024BZYLL0407

Approved file of Ethical Committee：

View

Name of the ethic committee：

ethics committee of Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/4/26 0:00:00

Contact Name of the ethic committee：

Mei, Li; Li hong, Zhao

Contact Address of the ethic committee：

11 North Third Ring Road East, Chaoyang District, Beijing

Contact phone of the ethic committee：

+86 10 5391 1431

Contact email of the ethic committee：

llbgs@bucm.edu.cn

Primary sponsor：

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine

Primary sponsor's address：

11 North Third Ring Road East, Chaoyang District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing University of Chinese Medicine

Address：

11 North Third Ring Road East, Chaoyang District, Beijing

Source(s) of funding：

2021 Qihuang Scholar Support Project

Target disease：

Acute postoperative pain after video-assisted thoracoscopic surgery

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This trial aims to assess the feasibility and efficacy of electroacupuncture combined with usual care versus sham electroacupuncture combined with usual care for acute postoperative pain after video-assisted thoracoscopic surgery.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Aged 18–75 years (either sex); ②Diagnosed with Non-small cell lung cancer before or during surgery; ③Undergoing VATS for pulmonary resection (including lung wedge resection, segmentectomy, and pulmonary lobectomy) for the first time; ④ With American Society of Anesthesiologists physical status I or II; ⑤Have no communication barriers and can cooperate with 3 months of telephone follow-up; ⑥Signed the informed consent.

Exclusion criteria：

①History of previous chest surgery (including but not limited to mastectomy, thoracotomy, and thoracoscopic surgery), as well as history of chronic pain; ②History of alcohol abuse or drug misuse; ③No preoperative respiratory infection, history of chronic cough and sputum production, or postnasal drip syndrome ④Have been receiving chemotherapy or radiation therapy, or have received acupuncture treatment in the past 3 months before the trial; ⑤Conversion to open surgery or require postoperative admission to the Intensive Care Unit; ⑥ Allergic to analgesic drugs and unwilling to use patient-controlled intravenous analgesia after surgery; ⑦Have other surgical plans within 3 months after the surgery; ⑧Neurologic illnesses, pregnancy, lactation period, severe hypertension, diabetes, cardiovascular disease, serious hepatic or renal insufficiency, infectious disease; ⑨Metal allergy, coagulation abnormalities, infections at the selected acupoint sites, and with implantable medical devices such as pacemakers; ⑩ Participating in other clinical trials.

Study execute time：

From 2024-08-07

To      2025-12-31

Recruiting time：

From 2024-08-15

To      2025-06-30

Interventions：

30

Group：

sham electroacupuncture group

Sample size：

Intervention：

sham electroacupuncture

Intervention code：

30

Group：

electroacupuncture group

Sample size：

Intervention：

electroacupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Cancer Hospital Chinese Academy of Medical Sciences

Level of the institution：

Tertiary A

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

The First Affiliated Hospital of Zhengzhou University

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Cough symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The pain score and incidence of chronic post-surgical pain

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chest tube duration

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pulmonary complications

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average pain score daily during mobilization

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average pain score daily during coughing

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average pain score daily during rest

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The first time of expectoration

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative rescue analgesics

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The average postoperative pain score during coughing within 72 hours after surgery

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Five-level EuroQol five-dimensional questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Length of postoperative hospital stay

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blinding assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Postoperative analgesic dosage

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

NA

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The stratified blocked randomization sequence is prepared by a professional statistician with the STATA software, who is not involved in assessment, treatment or analysis.

Blinding：

Group information was hidden from subjects, outcome evaluators and statistical analysts.

IPD sharing：

Yes

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

Open within 6 months after the trial complete, we will share IPD based on the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/)

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

The records of metadata are recorded through a CRF form. The data management will be handled by a dedicated person.

Data Managemen Committee：

Not yet

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

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