Bi-level vs. Single Level ESB in VATS

NCT05294315 | Unknown

• 1 other identifier: 120374
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Opioid use in first 12 postoperaive hour

  First 12 hour from arriving at postoperative recovery

Secondary Outcomes (4)

• Pain score area under curve first 12 hour

  First 12 hour from arriving at postoperative recovery

• Pain score area under curve first 24 hour

  First 24 hour from arriving at postoperative recovery

• Incidence of Acute block complication - based on clinical assessment

  First 12 hour since block placement

• Incidence of Delayed block complication - based on clinical assessment

  First 5 days

Study Arms (2)

Single level block arm - Control

ACTIVE COMPARATOR

Single level erector spinae block at 4th transverse process

Procedure: Single level erector spinae block

Bi-level block arm - Intervention

EXPERIMENTAL

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

Procedure: Bi-level erector spinae block

Interventions

Bi-level erector spinae block PROCEDURE

erector spinae block at 4th and 6th transverse process

Bi-level block arm - Intervention

Single level erector spinae block PROCEDURE

erector spinae block at 4th transverse process

Single level block arm - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Cheng Lin

London, Ontario, n6c6a7, Canada

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cheng Lin

CONTACT

5197025758; cheng.lin@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 24, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CA (1)