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

Primary Purpose

Thoracic

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ESP block
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic focused on measuring Thoracic surgical procedures

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interventional

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS)
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

opioid consumption
Total opioid consumption will calculate and record till the postoperative 48th hours.
opioid consumption
Total opioid consumption will calculate and record till the postoperative 3 months after surgery.
postoperative painDETECT score
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.
NRS
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).

Full Information

First Posted
December 20, 2019
Last Updated
October 13, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04208542
Brief Title
Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
Official Title
Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic
Keywords
Thoracic surgical procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ESP block
Intervention Description
Ultrasound guided Erector spinae block (ESP) will perform.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
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).
Time Frame
up to postoperative 48 hours.
Secondary Outcome Measure Information:
Title
opioid consumption
Description
Total opioid consumption will calculate and record till the postoperative 48th hours.
Time Frame
postoperative 48th hours
Title
opioid consumption
Description
Total opioid consumption will calculate and record till the postoperative 3 months after surgery.
Time Frame
3 months after surgery.
Title
postoperative painDETECT score
Description
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.
Time Frame
up to postoperative 3 months.
Title
NRS
Description
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).
Time Frame
up to postoperative 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female participants providing written informed consent, ASA grade 1-3, aged over 20 and under 80, primary lung cancer participants scheduled segmentectomy or lobectomy c MLND, undergoing a VATS procedure under General Anaesthesia Exclusion Criteria: Absence of informed written consent, chemotherapy before or after surgery, pre existing infection at block site, severe coagulopathy, pre existing neurological deficit, previous history of opiate abuse, pregnancy, pre existing chronic pain condition,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Jun Park
Phone
82-2-2228-2405
Email
iotas@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Jun Park, MD
Phone
82-2-2228-2405
Email
iotas@yuhs.ac

12. IPD Sharing Statement

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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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