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Continuous Erector Spinae Plane Block or Thoracic Epidural Analgesia Following Video Assisted Thoracic Surgery

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESP block (Group A)
TEA group (Group B)
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Video assisted thoracic surgery, Postoperative pain management, Erector spina plane block, Thoracic epidural analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for lVATS under general anesthesia

Exclusion Criteria:

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group ESPB = Erector spinae plane block group

Group TEA = Thoracic epidural analgesia group

Arm Description

ESP block (Group ESP) will be performed in the preoperative block room.A continuous infusion of 0.125% bupivacaine at the rate of 4 ml/h infusion dose, 6 ml bolus dose and 30 min lockout time will be performed till 48 h postoperative period.

TEA will be performed in the preoperative block room.A continuous infusion of 0.125% bupivacaine at the rate of 4 ml/h infusion dose, 6 ml bolus dose and 30 min lockout time will be performed till 48 h postoperative period.

Outcomes

Primary Outcome Measures

Postoperative pain scores
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16,and 24 hours.

Secondary Outcome Measures

Rescue analgesia need
Postoperative rescue analgesia need will be evaluated at postoperative 0, 2, 4, 8, 16, and 24 hours.

Full Information

First Posted
May 21, 2019
Last Updated
January 29, 2021
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT03960736
Brief Title
Continuous Erector Spinae Plane Block or Thoracic Epidural Analgesia Following Video Assisted Thoracic Surgery
Official Title
COMPARISON OF CONTINUOUS ERECTOR SPINAE PLANE BLOCK AND THORACIC EPIDURAL ANALGESIA FOR POSTOPERATİVE ANALGESIA MANAGEMENT FOLLOWING VIDEO ASSISTED THORACIC SURGERY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

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

5. Study Description

Brief Summary
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle (12). Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to compare US-guided continuous ESP block and TEA for postoperative analgesia management after VATS.
Detailed Description
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS procedures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Thoracic epidural analgesia (TEA) which is the gold standard analgesic technique after thoracotomy, is generally used for analgesia management after VATS. However, since the surgical technique and trauma between open surgery and VATS are different, the question of what should be the gold standard for analgesia management after VATS is a topic of discussion. Especially due to the difficult administration and adverse effect profile of TEA, the opinion of minimally invasive surgical procedures, requiring less invasive analgesic techniques is supported. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. The ESP block contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both posterior and anterolateral thorax. In the literature, it has been reported that ESP block provides effective analgesia after open heart surgery, breast surgery and ventral hernia repair in randomized controlled studies about ESP block efficiency for postoperative analgesia management. In some case series and case reports it has been reported that ESP block provides effective analgesia after thoracotomy and VATS. Furthermore, it has been reported that it provides effective analgesia in chronic and persistant pain syndromes of thorax. The aim of this study is to compare US-guided continuous ESP block and TEA for postoperative analgesia management after VATS. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting), complications due to blocks (pneumothorax, hematoma), and the time period and number of attempt for blocks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Video assisted thoracic surgery, Postoperative pain management, Erector spina plane block, Thoracic epidural analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for VATS under general anesthesia will be included in the study. Patients with a history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, and patients who do not accept the procedure will be excluded from the study. Randomization will be achieved using a randomizing computer program. Patients will be randomly divided into two groups (Group A = ESP group, Group B = TEA group) including 25 patients each, before entering the operating room.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and the patient will be blinded to the study
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ESPB = Erector spinae plane block group
Arm Type
Active Comparator
Arm Description
ESP block (Group ESP) will be performed in the preoperative block room.A continuous infusion of 0.125% bupivacaine at the rate of 4 ml/h infusion dose, 6 ml bolus dose and 30 min lockout time will be performed till 48 h postoperative period.
Arm Title
Group TEA = Thoracic epidural analgesia group
Arm Type
Active Comparator
Arm Description
TEA will be performed in the preoperative block room.A continuous infusion of 0.125% bupivacaine at the rate of 4 ml/h infusion dose, 6 ml bolus dose and 30 min lockout time will be performed till 48 h postoperative period.
Intervention Type
Other
Intervention Name(s)
ESP block (Group A)
Intervention Description
US probe will be placed longitudinally 2-3 cm lateral to the T5 transvers process. From superior to inferior, three muscles will be visualized on the hyperechoic transverse process; trapezius (upper), rhomboideus major (middle), erector spinae (lower). The block needle will be inserted cranio caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position 20G catheter will be inserted 5 cm in caudal direction. 20 ml %0.25 bupivacaine will be administered for block.
Intervention Type
Other
Intervention Name(s)
TEA group (Group B)
Intervention Description
Local infiltration with 2% of lidocaine under the skin, in T4/T5 intervertebral space will be administered. An 18 G Tuohy needle will be inserted at T4/T5 intervertebral space to identify epidural space using the loss of resistance technique. 20G catheter will be inserted 3-4 cm in caudal direction in the epidural space. Bolus dose of 0.125% bupivacaine 10 ml will be administered through the catheter after the negative aspiration for blood or cerebrospinal fluid
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16,and 24 hours.
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Rescue analgesia need
Description
Postoperative rescue analgesia need will be evaluated at postoperative 0, 2, 4, 8, 16, and 24 hours.
Time Frame
Postoperative 0, 2, 4, 8, 16, and 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for lVATS under general anesthesia Exclusion Criteria: Bleeding diathesis Receiving anticoagulant treatment Known local anesthetics and opioid allergy Infection of the skin at the site of the needle puncture Pregnancy or lactation Patients who do not accept the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, Asist.Prof
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
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PubMed Identifier
28252539
Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
Results Reference
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PubMed Identifier
30052229
Citation
Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
Results Reference
background
PubMed Identifier
29980005
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
Results Reference
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Continuous Erector Spinae Plane Block or Thoracic Epidural Analgesia Following Video Assisted Thoracic Surgery

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