Clinical trial NCT02959346: Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Official title: Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Pain Control
Randomized Controlled Trial
Thoracic Surgery
Keywords: Minimal invasive thoracoscopic surgery
Pain control
Acupuncture
Randomized controlled trial
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline pain scale at post operative day 2, after intervention
timeFrame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Secondary outcomes:
measure: Opioid dosage
timeFrame: injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
measure: Von Frey hair Test
timeFrame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
measure: Vital signs
timeFrame: measure during whole admission, an average of 7 days
measure: Questionnaire
timeFrame: measure before discharge, an average at post operative day 5
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Division of thoracic surgery, China medical university hospital
Study officials:
affiliation: Division of thoracic surgery, China medical university hospital, Taiwan
name: Ting Yu Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leaver HA, Craig SR, Yap PL, Walker WS. Lymphocyte responses following open and minimally invasive thoracic surgery. Eur J Clin Invest. 2000 Mar;30(3):230-8. doi: 10.1046/j.1365-2362.2000.00622.x.
citation: Rizk NP, Ghanie A, Hsu M, Bains MS, Downey RJ, Sarkaria IS, Finley DJ, Adusumilli PS, Huang J, Sima CS, Burkhalter JE, Park BJ, Rusch VW. A prospective trial comparing pain and quality of life measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann Thorac Surg. 2014 Oct;98(4):1160-6. doi: 10.1016/j.athoracsur.2014.05.028. Epub 2014 Jul 31.
citation: Mulder DS. Pain management principles and anesthesia techniques for thoracoscopy. Ann Thorac Surg. 1993 Sep;56(3):630-2. doi: 10.1016/0003-4975(93)90933-9.
citation: Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.
citation: Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. doi: 10.1142/S0192415X08006107.
citation: Lu KW, Hsu CK, Hsieh CL, Yang J, Lin YW. Probing the Effects and Mechanisms of Electroacupuncture at Ipsilateral or Contralateral ST36-ST37 Acupoints on CFA-induced Inflammatory Pain. Sci Rep. 2016 Feb 24;6:22123. doi: 10.1038/srep22123.
citation: Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
citation: Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
citation: Langenbach MR, Aydemir-Dogruyol K, Issel R, Sauerland S. Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy. Colorectal Dis. 2012 Aug;14(8):e486-91. doi: 10.1111/j.1463-1318.2012.02984.x.
citation: Sim CK, Xu PC, Pua HL, Zhang G, Lee TL. Effects of electroacupuncture on intraoperative and postoperative analgesic requirement. Acupunct Med. 2002 Aug;20(2-3):56-65. doi: 10.1136/aim.20.2-3.56.
citation: Lin JG, Lo MW, Wen YR, Hsieh CL, Tsai SK, Sun WZ. The effect of high and low frequency electroacupuncture in pain after lower abdominal surgery. Pain. 2002 Oct;99(3):509-514. doi: 10.1016/S0304-3959(02)00261-0.
citation: Wang RR, Tronnier V. Effect of acupuncture on pain management in patients before and after lumbar disc protrusion surgery--a randomized control study. Am J Chin Med. 2000;28(1):25-33. doi: 10.1142/S0192415X00000052.
citation: Ward U, Nilsson UG. Acupuncture for postoperative pain in day surgery patients undergoing arthroscopic shoulder surgery. Clin Nurs Res. 2013 Feb;22(1):130-6. doi: 10.1177/1054773812454136. Epub 2012 Jul 27.
citation: Coura LE, Manoel CH, Poffo R, Bedin A, Westphal GA. Randomised, controlled study of preoperative electroacupuncture for postoperative pain control after cardiac surgery. Acupunct Med. 2011 Mar;29(1):16-20. doi: 10.1136/aim.2010.003251.
citation: Gilbey P, Bretler S, Avraham Y, Sharabi-Nov A, Ibrgimov S, Luder A. Acupuncture for posttonsillectomy pain in children: a randomized, controlled study. Paediatr Anaesth. 2015 Jun;25(6):603-9. doi: 10.1111/pan.12621. Epub 2015 Feb 7.
citation: 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.