Bi-level vs. Single Level ESB in VATS

NCT ID: NCT05294315

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single level block arm - Control

Single level erector spinae block at 4th transverse process

Group Type ACTIVE_COMPARATOR

Single level erector spinae block

Intervention Type PROCEDURE

erector spinae block at 4th transverse process

Bi-level block arm - Intervention

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

Group Type EXPERIMENTAL

Bi-level erector spinae block

Intervention Type PROCEDURE

erector spinae block at 4th and 6th transverse process

Interventions

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Bi-level erector spinae block

erector spinae block at 4th and 6th transverse process

Intervention Type PROCEDURE

Single level erector spinae block

erector spinae block at 4th transverse process

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Cheng Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cheng Lin

London, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Cheng Lin

Role: CONTACT

5197025758

Other Identifiers

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120374

Identifier Type: -

Identifier Source: org_study_id

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