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Bi-level vs. Single Level ESB in VATS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05294315
Enrollment
90
Registered
2022-03-24
Start date
2022-06-01
Completion date
2023-02-01
Last updated
2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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.

Interventions

PROCEDUREBi-level erector spinae block

erector spinae block at 4th and 6th transverse process

PROCEDURESingle level erector spinae block

erector spinae block at 4th transverse process

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Opioid use in first 12 postoperaive hourFirst 12 hour from arriving at postoperative recovery

Secondary

MeasureTime frameDescription
Pain score area under curve first 12 hourFirst 12 hour from arriving at postoperative recoveryNumeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Pain score area under curve first 24 hourFirst 24 hour from arriving at postoperative recoveryNumeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain
Incidence of Acute block complication - based on clinical assessmentFirst 12 hour since block placementpneumothorax, local anesthetic toxicity, epidural spread, bleeding
Incidence of Delayed block complication - based on clinical assessmentFirst 5 daysparesthesia, motor weakness, hematoma, abscess

Countries

Canada

Contacts

Primary ContactCheng Lin
cheng.lin@lhsc.on.ca5197025758

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026