Bi-level vs. Single Level ESB in VATS

Not Applicable

• Conditions: Acute Pain
• Interventions: Procedure: Bi-level erector spinae block; Procedure: Single level erector spinae block

• Registration Number: NCT05294315
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-11
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Study Start: 2022-06-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bi-level block arm - Intervention	Bi-level erector spinae block	Bi-level erector spinae block at 4th and 6th transverse process
Single level block arm - Control	Single level erector spinae block	Single level erector spinae block at 4th transverse process

Primary Outcome Measures

Name	Time	Method
Opioid use in first 12 postoperaive hour	First 12 hour from arriving at postoperative recovery

Secondary Outcome Measures

Name	Time	Method
Incidence of Delayed block complication - based on clinical assessment	First 5 days	paresthesia, motor weakness, hematoma, abscess
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
Incidence of Acute block complication - based on clinical assessment	First 12 hour since block placement	pneumothorax, local anesthetic toxicity, epidural spread, bleeding
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

Trial Locations

Locations (1)

Cheng Lin; 🇨🇦 London, Ontario, Canada