Bi-level vs. Single Level ESB in VATS

The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: Single level erector spinae block; Procedure: Bi-level erector spinae block

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng Lin; Phone Number: 5197025758; Email: cheng.lin@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, n6c6a7
      • Cheng Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single level block arm - Control; Single level erector spinae block at 4th transverse process	Procedure: Single level erector spinae block; erector spinae block at 4th transverse process
Experimental: Bi-level block arm - Intervention; Bi-level erector spinae block at 4th and 6th transverse process	Procedure: Bi-level erector spinae block; erector spinae block at 4th and 6th transverse process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid use in first 12 postoperaive hour	First 12 hour from arriving at postoperative recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First 12 hour from arriving at postoperative recovery
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	First 24 hour from arriving at postoperative recovery
Incidence of Acute block complication - based on clinical assessment	pneumothorax, local anesthetic toxicity, epidural spread, bleeding	First 12 hour since block placement
Incidence of Delayed block complication - based on clinical assessment	paresthesia, motor weakness, hematoma, abscess	First 5 days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 120374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No