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Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Primary Purpose

Acupuncture, Pain Control, Randomized Controlled Trial

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sham Acupuncture
Acupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring Minimal invasive thoracoscopic surgery, Pain control, Acupuncture, Randomized controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of thoracic surgery, China medical university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Acupuncture

Acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Vital signs
Measure at every 9AM, 1PM, 5PM and 9PM Including blood pressure, heart rate, breath rate, body temperature
Questionnaire
1. Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days

Full Information

First Posted
November 3, 2016
Last Updated
December 8, 2016
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02959346
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Pain Control, Randomized Controlled Trial, Thoracic Surgery
Keywords
Minimal invasive thoracoscopic surgery, Pain control, Acupuncture, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture.
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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 Measure Information:
Title
Change from baseline pain scale at post operative day 2, after intervention
Description
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
Time Frame
measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Secondary Outcome Measure Information:
Title
Opioid dosage
Description
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
Time Frame
injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
Title
Von Frey hair Test
Description
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
Time Frame
measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Title
Vital signs
Description
Measure at every 9AM, 1PM, 5PM and 9PM Including blood pressure, heart rate, breath rate, body temperature
Time Frame
measure during whole admission, an average of 7 days
Title
Questionnaire
Description
1. Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days
Time Frame
measure before discharge, an average at post operative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Yu Lu, MD
Phone
+886-975682784
Email
seawindss@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Yu Lu, MD
Organizational Affiliation
Division of thoracic surgery, China medical university hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of thoracic surgery, China medical university hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Yu Lu, MD
Phone
+886-975682784
Email
seawindss@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

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