Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Not Applicable

• Conditions: Acupuncture; Pain Control; Randomized Controlled Trial; Thoracic Surgery
• Interventions: Procedure: Sham Acupuncture; Procedure: Acupuncture

• Registration Number: NCT02959346
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-05
• Study First Posted: 2016-11-09
• Status Verified: 2016-12
• Study Start: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture	Sham Acupuncture	After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture.
Acupuncture	Acupuncture	After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.

Primary Outcome Measures

Name	Time	Method
Change from baseline pain scale at post operative day 2, after intervention	measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention	1. Pain, as assessed by Numeric Rating Scale, NRS; 2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention; 3. accompanied with rest, deep breath, cough and change posture by left and right decubitus

Secondary Outcome Measures

Name	Time	Method
Vital signs	measure during whole admission, an average of 7 days	1. Measure at every 9AM, 1PM, 5PM and 9PM; 2. Including blood pressure, heart rate, breath rate, body temperature
Questionnaire	measure before discharge, an average at post operative day 5	1. Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days
Opioid dosage	injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days	1. Routine pain control was given with oral form acetaminophen (500mg, at every 9AM, 1PM, 5PM and 9PM); 2. Additional Morphine was given for intolerable pain (0.05mg/kg, intramuscular injection); 3. Additional Ketorolac was given for intolerable pain after morphine used (15mg, intramuscular injection); 4. Avoid patient controlled analgesia (PCA) using
Von Frey hair Test	measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention	1. Pain, as assessed by von Frey hair Test at each wound sites; 2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention

Trial Locations

Locations (1)

Division of thoracic surgery, China medical university hospital; 🇨🇳 Taichung, Taiwan