search
Back to results

Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spinae plane block (Group ESPB)
Thoracal paravertebral block (Group TPVB)
Control group (group C)
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 Erector spinae plane block, Video assisted thoracic surgery,, Postoperative 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 VATS under general anesthesia

Exclusion Criteria:

  • 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,
  • patients who do not accept the procedure

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Erector spinae block (Group ESPB)

Thoracal paravertebral block group (Group TPVB)

Control group (Group C)

Arm Description

In group A, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse 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 of the needle 20 ml %0.25 bupivacaine will be administered for block.

In group B, TPVB will be performed. US probe will be placed 2-3 cm laterally following the visualization T5 spinous process in sagittal orientation. The ribs and transverse processes will be visualized as hyperechoic structures. The costotransverse ligament will be visualized in the superior, and the pleura in the anterior region. Using in plane technique, the block needle will be inserted in the cranio-caudal direction until the costotransverse ligament will be passed. For confirmation of correct position of the needle, 5 ml saline will be injected. After the negative aspiration of cerebrospinal fluid, blood and air; 20 ml of 0.25% bupivacaine will be performed and it will be seen of moving downwards of the pleura during the injection

Patients in control group will be only received fentanyl via a patient controlled analgesia (PCA) device.

Outcomes

Primary Outcome Measures

opioid consumption
The primary aim is to compare perioperative and postoperative opioid consumption

Secondary Outcome Measures

Visual analogue scores (VAS)
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 1, 2, 4, 8, 16 and 24 hours.

Full Information

First Posted
February 22, 2019
Last Updated
May 8, 2020
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT03854773
Brief Title
Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery
Official Title
Comparison Of Erector Spinae Plane Block And Thoracal Paravertebral Block For Postoperative Analgesia Management Following Vıdeo Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (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 ESP block and TPVB 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. Thoracic paravertebral block (TPVB) has been evaluated as the first step regional analgesia technique for postoperative analgesia management after VATS. However, its administration is difficult because of its anatomical proximity to important structures such as the pleura and central neuro-axial system and it can cause complications such as pneumothorax, vascular injury. 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 ESP block and TPVB 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) and complications due to blocks (pneumothorax, hematoma).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
there are three models for this study. the first group is erector spinae plane block group. the second one is thoracal paravertebral block group. the third one is the control group.
Masking
ParticipantOutcomes Assessor
Masking Description
the patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae block (Group ESPB)
Arm Type
Active Comparator
Arm Description
In group A, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse 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 of the needle 20 ml %0.25 bupivacaine will be administered for block.
Arm Title
Thoracal paravertebral block group (Group TPVB)
Arm Type
Active Comparator
Arm Description
In group B, TPVB will be performed. US probe will be placed 2-3 cm laterally following the visualization T5 spinous process in sagittal orientation. The ribs and transverse processes will be visualized as hyperechoic structures. The costotransverse ligament will be visualized in the superior, and the pleura in the anterior region. Using in plane technique, the block needle will be inserted in the cranio-caudal direction until the costotransverse ligament will be passed. For confirmation of correct position of the needle, 5 ml saline will be injected. After the negative aspiration of cerebrospinal fluid, blood and air; 20 ml of 0.25% bupivacaine will be performed and it will be seen of moving downwards of the pleura during the injection
Arm Title
Control group (Group C)
Arm Type
Other
Arm Description
Patients in control group will be only received fentanyl via a patient controlled analgesia (PCA) device.
Intervention Type
Other
Intervention Name(s)
Erector spinae plane block (Group ESPB)
Intervention Description
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Intervention Type
Other
Intervention Name(s)
Thoracal paravertebral block (Group TPVB)
Intervention Description
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Intervention Type
Other
Intervention Name(s)
Control group (group C)
Intervention Description
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Primary Outcome Measure Information:
Title
opioid consumption
Description
The primary aim is to compare perioperative and postoperative opioid consumption
Time Frame
Change from Baseline Postoperative Visual Analogue Score at 48 hours
Secondary Outcome Measure Information:
Title
Visual analogue scores (VAS)
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 1, 2, 4, 8, 16 and 24 hours.
Time Frame
postoperative 1, 2, 4, 8, 16, 24, and 48 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 VATS under general anesthesia Exclusion Criteria: 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, patients who do not accept the procedure
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
we will not share IPD
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
background
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
background
PubMed Identifier
16199417
Citation
Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.
Results Reference
background

Learn more about this trial

Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery

We'll reach out to this number within 24 hrs