Bi-level vs. Single Level ESB in VATS

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05294315
• Other study ID #: 120374
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2022
• Source: Lawson Health Research Institute
• Contact: Cheng Lin
• Phone: 5197025758
• Email: cheng.lin[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Procedure:
• Bi-level erector spinae block
erector spinae block at 4th and 6th transverse process
• Single level erector spinae block
erector spinae block at 4th transverse process

Locations

Country	Name	City	State
Canada	Cheng Lin	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use in first 12 postoperaive hour		First 12 hour from arriving at postoperative recovery
Secondary	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
Secondary	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
Secondary	Incidence of Acute block complication - based on clinical assessment	pneumothorax, local anesthetic toxicity, epidural spread, bleeding	First 12 hour since block placement
Secondary	Incidence of Delayed block complication - based on clinical assessment	paresthesia, motor weakness, hematoma, abscess	First 5 days