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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 : Unknown
Verified December 2016 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 9, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2016)
Change from baseline pain scale at post operative day 3, after intervention [ Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 3, 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 3, 5PM, after intervention
  3. accompanied with rest, deep breath, cough and change posture by left and right decubitus
Change History Complete list of historical versions of study NCT02959346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2016)
  • 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 (0.5mg/kg, intramuscular injection)
    3. Additional Ketorolac was given for intolerable pain after morphine used (15mg, intramuscular injection)
    4. Avoid patient controlled analgesia (PCA) using
  • Pulmonary function [ Time Frame: measure before operation; at post-operative day 1, 9AM, before intervention; and post-operative day 3, 5PM, after intervention ]
    1. Measure FEV1, FEV1/FVC
    2. Measure before operation; at post-operative day 1, 9AM, before intervention; and post-operative day 3, 5PM, after intervention
  • Von Frey hair Test [ Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 3, 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 3, 5PM, after intervention
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
Official Title  ICMJE Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acupuncture
  • Pain Control
  • Randomized Controlled Trial
  • Thoracic Surgery
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Sham Acupuncture
  • Experimental: Acupuncture
    After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.
    Intervention: Procedure: Acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 5, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02959346
Other Study ID Numbers  ICMJE CMUH105-REC2-097
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ting Yu Lu, MD Division of thoracic surgery, China medical university hospital, Taiwan
PRS Account China Medical University Hospital
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP