Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

NCT02959346 | Unknown DMC

• 1 other identifier: CMUH105-REC2-097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Pain Control; Randomized Controlled Trial; Thoracic Surgery

Keywords

Minimal invasive thoracoscopic surgery; Pain control; Acupuncture; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain scale at post operative day 2, 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

  measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention

Secondary Outcomes (4)

• Opioid dosage

  injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days

• Von Frey hair Test

  measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention

• Vital signs

  measure during whole admission, an average of 7 days

• Questionnaire

  measure before discharge, an average at post operative day 5

Study Arms (2)

Sham Acupuncture

SHAM COMPARATOR

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

Acupuncture

EXPERIMENTAL

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

Procedure: Acupuncture

Interventions

Sham Acupuncture PROCEDURE

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.

Sham Acupuncture

Acupuncture PROCEDURE

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.

Acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Division of thoracic surgery, China medical university hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (16)

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  PMID: 10692000 BACKGROUND

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  PMID: 19794994 BACKGROUND

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  PMID: 18711761 BACKGROUND

• 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.

  PMID: 26906464 BACKGROUND

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  PMID: 9249122 BACKGROUND

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  PMID: 22330010 BACKGROUND

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  PMID: 12216602 BACKGROUND

• 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.

  PMID: 12406527 BACKGROUND

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MeSH Terms

Conditions

Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ting Yu Lu, MD

  Division of thoracic surgery, China medical university hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Yu Lu, MD

CONTACT

+886-975682784; seawindss@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 9, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)