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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 January 2017
Main ID:  NCT02959346
Date of registration: 03/11/2016
Prospective Registration: Yes
Primary sponsor: China Medical University Hospital
Public title: Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Scientific title: Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Date of first enrolment: December 2016
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02959346
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Ting Yu Lu, MD
Address: 
Telephone: +886-975682784
Email: seawindss@hotmail.com
Affiliation: 
Name:     Ting Yu Lu, MD
Address: 
Telephone: +886-975682784
Email: seawindss@hotmail.com
Affiliation: 
Name:     Ting Yu Lu, MD
Address: 
Telephone:
Email:
Affiliation:  Division of thoracic surgery, China medical university hospital, Taiwan
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age more than 20-year-old

- Both male and female patients

- Nationality: Republic of China (R.O.C., Taiwan)

- Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung
tumor, primary lung cancer, mediastinal tumor

Exclusion Criteria:

- Abnormal function of coagulation

- Platelet count less than 20 x 10^3/mm^3

- International normalized ratio (INR) more than 2.5

- Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal
failure

- Who would not cooperate in access, or express appropriately



Age minimum: 20 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Pain Control
Randomized Controlled Trial
Thoracic Surgery
Acupuncture
Intervention(s)
Procedure: Acupuncture
Procedure: Sham Acupuncture
Primary Outcome(s)
Change from baseline pain scale at post operative day 2, after intervention [Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention]
Secondary Outcome(s)
Questionnaire [Time Frame: measure before discharge, an average at post operative day 5]
Opioid dosage [Time Frame: injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days]
Vital signs [Time Frame: measure during whole admission, an average of 7 days]
Von Frey hair Test [Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention]
Secondary ID(s)
CMUH105-REC2-097
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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