Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

China Medical University

Status: Unknown

Conditions: Pain Control; Randomized Controlled Trial; Acupuncture; Thoracic Surgery

Treatments: Procedure: Sham Acupuncture; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02959346

CMUH105-REC2-097

Details and patient eligibility

About

Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.

In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.

The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.

The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.

Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sham Acupuncture

Sham Comparator group

Description:

After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture.

Treatment:

Procedure: Sham Acupuncture

Acupuncture

Experimental group

Description:

After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.

Treatment:

Procedure: Acupuncture