Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959346
• Other study ID #: CMUH105-REC2-097
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2016
• Last updated: December 8, 2016
• Start date: December 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2016
• Source: China Medical University Hospital
• Contact: Ting Yu Lu, MD
• Phone: +886-975682784
• Email: seawindss[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acupuncture
• Pain Control
• Pain, Postoperative
• Randomized Controlled Trial
• Thoracic Surgery

Intervention

Procedure:
• Sham Acupuncture
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.
• Acupuncture
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.

Locations

Country	Name	City	State
Taiwan	Division of thoracic surgery, China medical university hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. Review. — View 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):509-14. — View 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. — View Citation

Mulder DS. Pain management principles and anesthesia techniques for thoracoscopy. Ann Thorac Surg. 1993 Sep;56(3):630-2. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

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