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Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

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ClinicalTrials.gov Identifier: NCT04208542
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
This is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for VATS procedures. It will include 72 patients presenting to Severance hospital for a VATS procedure. Patients will be randomized 1:1 to receive either ESP block and intravenous patient-controlled analgesia (IV PCA) or IV PCA only. Ropivacaine will be used in nerve block, and injected at the end of surgery. The primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. Secondary outcomes include total opioid consumption, painDETECT score, and chronic pain scores.

Condition or disease Intervention/treatment Phase
Thoracic Drug: ESP block Phase 4

Detailed Description:

Postoperative pain control for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Poorly controlled acute pain may contribute to the impairment of respiratory function and the development of chronic post-thoracotomy pain.

Recently, an increasing number of erector spinae plane (ESP) nerve blocks are being performed as it has been demonstrated, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block and epidural analgesia. Moreover, there is an advantage for novice because ESP block is simpler and safer to proceed than conventional nerve blocks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups of patients will be studied simultaneously. One group will have the intervention of the ESP block and IV PCA. The other group will have only IV PCA.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Both participants and anesthesia provider will not know which intervention applied. Another anesthesia provider who did not perform nerve block will follow and record to the study data.
Primary Purpose: Treatment
Official Title: Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Interventional
Under general anaesthesia, ultrasound guided ESP block will perform at the T5 level with 0.375% ropivacaine 20ml. Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.
Drug: ESP block
Ultrasound guided Erector spinae block (ESP) will perform.

No Intervention: Control
Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.



Primary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: up to postoperative 48 hours. ]

    These scores will record till the postoperative 48 hours.

    - The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).



Secondary Outcome Measures :
  1. opioid consumption [ Time Frame: postoperative 48th hours ]
    Total opioid consumption will calculate and record till the postoperative 48th hours.

  2. opioid consumption [ Time Frame: 3 months after surgery. ]
    Total opioid consumption will calculate and record till the postoperative 3 months after surgery.

  3. postoperative painDETECT score [ Time Frame: up to postoperative 3 months. ]
    painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded −1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain.

  4. NRS [ Time Frame: up to postoperative 3 months. ]

    NRS will record at postoperative 3 months.

    - The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and Female participants providing written informed consent,
  2. ASA grade 1-3,
  3. aged over 20 and under 80,
  4. primary lung cancer participants scheduled segmentectomy or lobectomy c MLND,
  5. undergoing a VATS procedure under General Anaesthesia

Exclusion Criteria:

  1. Absence of informed written consent,
  2. chemotherapy before or after surgery,
  3. pre existing infection at block site,
  4. severe coagulopathy,
  5. pre existing neurological deficit,
  6. previous history of opiate abuse,
  7. pregnancy,
  8. pre existing chronic pain condition,

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): NCT04208542


Contacts
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Contact: Sang Jun Park 82-2-2228-2405 iotas@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Contact: Sang Jun Park, MD    82-2-2228-2405    iotas@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04208542    
Other Study ID Numbers: 4-2019-0500
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Thoracic surgical procedures
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms