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Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

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ClinicalTrials.gov Identifier: NCT02959346
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acupuncture Pain Control Randomized Controlled Trial Thoracic Surgery Procedure: Sham Acupuncture Procedure: Acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Study Start Date : December 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: 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.
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.


Experimental: Acupuncture
After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.
Procedure: 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.





Primary Outcome Measures :
  1. Change from baseline pain scale at post operative day 2, after intervention [ Time Frame: 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 :
  1. Opioid dosage [ Time Frame: 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

  2. Von Frey hair Test [ Time Frame: 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

  3. Vital signs [ Time Frame: 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

  4. Questionnaire [ Time Frame: 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959346


Contacts
Contact: Ting Yu Lu, MD +886-975682784 seawindss@hotmail.com

Locations
Taiwan
Division of thoracic surgery, China medical university hospital Recruiting
Taichung, Taiwan, 404
Contact: Ting Yu Lu, MD    +886-975682784    seawindss@hotmail.com   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Ting Yu Lu, MD Division of thoracic surgery, China medical university hospital, Taiwan

Publications:

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02959346     History of Changes
Other Study ID Numbers: CMUH105-REC2-097
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by China Medical University Hospital:
Minimal invasive thoracoscopic surgery
Pain control
Acupuncture
Randomized controlled trial

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms