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Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound guided erector spinae plane block
Intercostal block
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring regional, erector spinae block, lobectomy, video-assisted

Eligibility Criteria

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

Inclusion Criteria:

  • Elective video-assisted thoracoscopic surgeries (VATS) lobectomies
  • Elective video-assisted thoracoscopic surgeries (VATS) wedge resections

Exclusion Criteria:

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ESP for VATS

ICB for VATS

Arm Description

Erector Spinae plane (ESP) block

Intercostal block (ICB)

Outcomes

Primary Outcome Measures

Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.
Number of patients recruited per week
Number of adverse events (AEs) which can be attributed to the ESP block which is defines as the number of AEs occuring per week.
Number of adverse events

Secondary Outcome Measures

Pain scores at rest and on movement
Pain scores will be recorded at intervals
Dermatome distribution to test loss of sensation to pinpricks
The dermatome distribution on the patient's anterior chest, mid-axillary line and back will be collected using a blunt needle to test for loss of sensation to pinpricks.

Full Information

First Posted
May 24, 2017
Last Updated
September 9, 2019
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03176667
Brief Title
Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy
Official Title
Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS) Lobectomy or Wedge Resections - a Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton

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
This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.
Detailed Description
Video assisted thoracoscopic surgery (VATS) has become an increasingly popular technique in thoracic surgery with improvement in technology. It provides significant advantages over open thoracotomy procedures including reduced acute pain, reduced mortality, improved post-operative pulmonary function, and shorter hospitalization stays. Nevertheless, there is still considerable amount of post-operative acute pain with VATS lobectomies. Controlling post-operative pain is crucial because increased acute pain has been associated with the development of chronic pain. Many patients receive either thoracic epidural (TEA) or paravertebral blocks (PVB) to treat post-operative pain in thoracotomy procedures as these techniques remain the gold standard. In contrast to thoracotomy procedures, it is unclear which is the best approach to analgesia is in VATS. A few studies have found no benefit in pain scores, patient satisfaction, pulmonary function, and incidence of side effects when comparing TEA with opioid patient controlled analgesia in VATS. Other studies have found minimal benefit in pain scores with TEA. The PVB has been used as alternative to TEA. One prospective observational study using PVB and continuous intercostal catheter demonstrated lower pain scores in VATS lobectomy. A randomized control trial (RCT) comparing PVB with wound infiltration in VATS lobectomy showed lower pain scores, lower morphine consumption, and higher patient satisfaction. However, both TEA and PVB have potential serious side-effects and complications. Complications of TEA include severe hypotension, epidural abscess, epidural hematomas and spinal cord injury. PVB have less incidence of hypotension but may involve risks like pneumothorax, pleural and vascular puncture, and higher systemic absorption of local anesthetics. PVB is also technically challenging and its spread is not reliable likely due to the presence of the endothoracic fasica. In addition, placement of both TEA and PVB require appropriate discontinuation of anticoagulants. Intercostal nerve blocks have been used as an analgesic alternative to TEA and PVB. One RCT found patients who had received intercostal blocks undergoing bilateral VATS for hyperhidrosis had lower pain scores in the post-anesthesia recovery unit (PACU). A combined retrospective and prospective study examined the analgesic effect and duration of intercostal blocks in patients undergoing VATS. The authors found that intercostal blocks decreased morphine consumption in the first 24 hours and the analgesic effect of the block lasted approximately 16 hours. Intercostal blocks appear to have some analgesic effect in the immediate post-operative period but are short-lived unless a catheter is placed. The standard practice for post-operative pain management for VATS lobectomy at St. Joseph's hospital consists of intercostal blocks performed by the thoracic surgeons at the end of surgery in combination with patient-controlled analgesia (PCA). A novel regional technique called the Erector Spinae Plane (ESP) block has been recently described. This interfascial block involves ultrasound guided injection of local anesthetics posterior to the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block appears to target the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The ESP block has been successfully applied in multiple clinical settings. For example, several patients suffering from chronic thoracic neuropathic pain achieved significant analgesia after receiving ESP blocks. ESP blocks have also been used as a rescue analgesia for a patient who failed a TEA after thoracotomy. Other applications include ventral hernia repair in abdominal surgery. The simplicity and safety of the ESP block has been proposed as its main advantages. Because it is a superficial interfascial plane block, it is distant from both the spinal cord and pleura. The ESP block is technically an easy to perform under ultrasound guidance due to its superficial location. There is also theoretically less possibility of needle related complications as the transverse process acts as a backstop for needle advancement. A catheter can be placed easily during the ESP block allowing continuous infusion and prolonged analgesia. Given the importance of providing adequate analgesia in VATS lobectomy and wedge resections and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, the investigators are proposing a prospective observational study to examine the analgesic efficacy of the ESP block in VATS lobectomy or wedge resections as a potential alternative to TEA, PVB and intercostal blocks. The investigators are hoping the results of this study will provide framework for future larger comparative studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
regional, erector spinae block, lobectomy, video-assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP for VATS
Arm Type
Experimental
Arm Description
Erector Spinae plane (ESP) block
Arm Title
ICB for VATS
Arm Type
Active Comparator
Arm Description
Intercostal block (ICB)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided erector spinae plane block
Intervention Description
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process. The trapezius, rhomboid major, and erector spinae muscles will then be identified superficial to the tip of the T5 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.5% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg), followed by insertion of a 19-gauge catheter under direct vision 5 cm beyond the needle tip. The catheter will then be secured in place.
Intervention Type
Procedure
Intervention Name(s)
Intercostal block
Intervention Description
The surgeons will identify the desired rib, and advance the needle at an approximately 20-degree angle until contact with rib is made, the needle is then walked of the inferior border of the rib and advanced slightly to plaice the tip of the needle in the neurovascular bundle. The intercostal nerve blocks will be performed at T4-T11 using 0.25% Marcaine with epinephrine and a volume of 5 ml per block (maximum of 2.5mg/kg) after negative aspiration has been confirmed.
Primary Outcome Measure Information:
Title
Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.
Description
Number of patients recruited per week
Time Frame
One week
Title
Number of adverse events (AEs) which can be attributed to the ESP block which is defines as the number of AEs occuring per week.
Description
Number of adverse events
Time Frame
One week
Secondary Outcome Measure Information:
Title
Pain scores at rest and on movement
Description
Pain scores will be recorded at intervals
Time Frame
Two days post-operatively
Title
Dermatome distribution to test loss of sensation to pinpricks
Description
The dermatome distribution on the patient's anterior chest, mid-axillary line and back will be collected using a blunt needle to test for loss of sensation to pinpricks.
Time Frame
Two days post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective video-assisted thoracoscopic surgeries (VATS) lobectomies Elective video-assisted thoracoscopic surgeries (VATS) wedge resections Exclusion Criteria: Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18713924
Citation
Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.
Results Reference
background
PubMed Identifier
10421140
Citation
Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. doi: 10.1016/s0003-4975(99)00467-1.
Results Reference
background
PubMed Identifier
19794994
Citation
Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.
Results Reference
background
PubMed Identifier
22219442
Citation
Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
Results Reference
background
PubMed Identifier
33627193
Citation
Horth D, Sanh W, Moisiuk P, O'Hare T, Shargall Y, Finley C, Hanna W, Agzarian J, Forero M, Davis K, Vanniyasingam T, Thabane L, Shanthanna H. Continuous erector spinae plane block versus intercostal nerve block in patients undergoing video-assisted thoracoscopic surgery: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Feb 24;7(1):56. doi: 10.1186/s40814-021-00801-7.
Results Reference
derived

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Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy

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