Thoracic Surgery Clinical Trial
Official title:
Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Division of thoracic surgery, China medical university hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
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Deng G, Rusch V, Vickers A, Malhotra V, Ginex P, Downey R, Bains M, Park B, Rizk N, Flores R, Yeung S, Cassiletha B. Randomized controlled trial of a special acupuncture technique for pain after thoracotomy. J Thorac Cardiovasc Surg. 2008 Dec;136(6):1464-9. doi: 10.1016/j.jtcvs.2008.07.053. — View Citation
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Mulder DS. Pain management principles and anesthesia techniques for thoracoscopy. Ann Thorac Surg. 1993 Sep;56(3):630-2. Review. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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