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Bi-level vs. Single Level ESB in VATS

Primary Purpose

Acute Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bi-level erector spinae block
Single level erector spinae block
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

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

Inclusion Criteria:

  • adult patients (at least 18 years old)
  • elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS

Exclusion Criteria:

  • history of malignant hyperthermia
  • BMI > 40, chronic pain condition
  • Daily opioid consumption of more than 60 mg oral morphine equivalents
  • Conversion to thoracotomy
  • Insertion of epidural
  • postoperative admission to ICU

Sites / Locations

  • Cheng Lin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single level block arm - Control

Bi-level block arm - Intervention

Arm Description

Single level erector spinae block at 4th transverse process

Bi-level erector spinae block at 4th and 6th transverse process

Outcomes

Primary Outcome Measures

Opioid use in first 12 postoperaive hour

Secondary Outcome Measures

Pain score area under curve first 12 hour
Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Pain score area under curve first 24 hour
Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Incidence of Acute block complication - based on clinical assessment
pneumothorax, local anesthetic toxicity, epidural spread, bleeding
Incidence of Delayed block complication - based on clinical assessment
paresthesia, motor weakness, hematoma, abscess

Full Information

First Posted
January 11, 2022
Last Updated
March 15, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05294315
Brief Title
Bi-level vs. Single Level ESB in VATS
Official Title
The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

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 thoracoscopic surgery (VATS) is a minimally invasive surgery to remove lesions from the thoracic cavity. It is associated with moderate pain which can lead to pulmonary complications after surgery. The Enhanced Recovery After Surgery (ERAS) and the European Society of Thoracic Surgeons recommended a multimodal analgesia approach to manage pain after VATS. Erector spinae block (ESB) is a popular analgesic block due to its ease of performance and wide coverage. It has been shown to be effective in randomized control trials. Recently, case reports on bi-level ESB are emerging, suggesting more effective analgesia compared to single level ESB. As there is no available data, the investigators are interested in conducting a randomized pilot study, comparing bi-level to single level ESB to gather baseline data for sample size calculation for a formal randomized trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single level block arm - Control
Arm Type
Active Comparator
Arm Description
Single level erector spinae block at 4th transverse process
Arm Title
Bi-level block arm - Intervention
Arm Type
Experimental
Arm Description
Bi-level erector spinae block at 4th and 6th transverse process
Intervention Type
Procedure
Intervention Name(s)
Bi-level erector spinae block
Intervention Description
erector spinae block at 4th and 6th transverse process
Intervention Type
Procedure
Intervention Name(s)
Single level erector spinae block
Intervention Description
erector spinae block at 4th transverse process
Primary Outcome Measure Information:
Title
Opioid use in first 12 postoperaive hour
Time Frame
First 12 hour from arriving at postoperative recovery
Secondary Outcome Measure Information:
Title
Pain score area under curve first 12 hour
Description
Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Time Frame
First 12 hour from arriving at postoperative recovery
Title
Pain score area under curve first 24 hour
Description
Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Time Frame
First 24 hour from arriving at postoperative recovery
Title
Incidence of Acute block complication - based on clinical assessment
Description
pneumothorax, local anesthetic toxicity, epidural spread, bleeding
Time Frame
First 12 hour since block placement
Title
Incidence of Delayed block complication - based on clinical assessment
Description
paresthesia, motor weakness, hematoma, abscess
Time Frame
First 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients (at least 18 years old) elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS Exclusion Criteria: history of malignant hyperthermia BMI > 40, chronic pain condition Daily opioid consumption of more than 60 mg oral morphine equivalents Conversion to thoracotomy Insertion of epidural postoperative admission to ICU
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Lin
Phone
5197025758
Email
cheng.lin@lhsc.on.ca
Facility Information:
Facility Name
Cheng Lin
City
London
State/Province
Ontario
ZIP/Postal Code
n6c6a7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bi-level vs. Single Level ESB in VATS

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