Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Conditions
-----------------
Acupuncture, Pain Control, Randomized Controlled Trial, Thoracic Surgery

Intervention / Treatment
-----------------
* Procedure: Sham Acupuncture
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Acupuncture<br>After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture. | Procedure: Sham Acupuncture<br>* Procedure: Sham Acupuncture(ipisilateral side, 0.3cun, No needle sensation (de qi) was elicited) Sham acupuncture will be applied by inserting acupuncture needle into acupoints(1cm away from the true acupoint):upper limb: Waiguan TE5; lower limb: Zusanli ST36. All procedures were carried out to a depth of 0.5 cm with disposable needles measuring 0.16 mm in diameter (40-gauge) and 12.7 mm in length (Yu Kuang, Taipei, Taiwan). Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.<br>|
| Experimental: Acupuncture<br>After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture. | Procedure: Acupuncture<br>* Procedure: Acupuncture(ipisilateral side, the needling depth decided by whether patients feel De qi, neutral supplementation and draining) Acupuncture will be applied by inserting acupuncture needle into acupoints: Zhigou TE6, Shousanli LI10, Hegu LI4, Neiguan PC6, Houxi SI3; lower limb: Biguan ST31, Fushe SP13, Zulinqi GB41; axillary area(Remove Needles right away after De qi): Yuanye GB22, Jiquan HT1; local area(Remove Needles right away after De qi): ashi point close to the pain area. The other needles will be left for 20 minutes and then removed. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length (Yu Kuang, Taipei, Taiwan). Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain scale at post operative day 2, after intervention | Pain, as assessed by Numeric Rating Scale, NRS Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention accompanied with rest, deep breath, cough and change posture by left and right decubitus | measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid dosage | Routine pain control was given with oral form acetaminophen (500mg, at every 9AM, 1PM, 5PM and 9PM) Additional Morphine was given for intolerable pain (0.05mg/kg, intramuscular injection) Additional Ketorolac was given for intolerable pain after morphine used (15mg, intramuscular injection) Avoid patient controlled analgesia (PCA) using | injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days | 
| Von Frey hair Test | Pain, as assessed by von Frey hair Test at each wound sites Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention | measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention | 
| Vital signs | Measure at every 9AM, 1PM, 5PM and 9PM Including blood pressure, heart rate, breath rate, body temperature | measure during whole admission, an average of 7 days | 
| Questionnaire | 1. Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days | measure before discharge, an average at post operative day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain control, Minimal invasive thoracoscopic surgery, Acupuncture, Randomized controlled trial