Bi-level vs. Single Level ESB in VATS

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05294315
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 11.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Procedure: Bi-level erector spinae block; Procedure: Single level erector spinae block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Opioid use in first 12 postoperaive hour [First 12 hour from arriving at postoperative recovery]

Secondary Outcome Measures

1. Pain score area under curve first 12 hour [First 12 hour from arriving at postoperative recovery]

   Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain

2. Pain score area under curve first 24 hour [First 24 hour from arriving at postoperative recovery]

   Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain

3. Incidence of Acute block complication - based on clinical assessment [First 12 hour since block placement]

   pneumothorax, local anesthetic toxicity, epidural spread, bleeding

4. Incidence of Delayed block complication - based on clinical assessment [First 5 days]

   paresthesia, motor weakness, hematoma, abscess

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheng Lin	London	Ontario	Canada	n6c6a7

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cheng Lin, Clinical Professor, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT05294315
• Other Study ID Numbers: 120374
• First Posted: Mar 24, 2022
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain

Study Results

No Results Posted as of Mar 24, 2022