Acute PainNCT05294315
Bi-level vs. Single Level ESB in VATS
A study testing Bi-level erector spinae block and Single level erector spinae block in people with Acute Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Bi-level erector spinae block and Single level erector spinae block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (at least 18 years old)
- elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study
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.
- Conditions
- Acute Pain
- Being tested
- Bi-level erector spinae block, Single level erector spinae block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-level erector spinae blockProcedure or surgery
erector spinae block at 4th and 6th transverse process
Single level erector spinae blockProcedure or surgery
erector spinae block at 4th transverse process
| Study group | Role | What they receive |
|---|---|---|
| Single level block arm - Control | Active comparator | Single level erector spinae block at 4th transverse process Receives: Procedure: Single level erector spinae block |
| Bi-level block arm - Intervention | Experimental | Bi-level erector spinae block at 4th and 6th transverse process Receives: Procedure: Bi-level erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use in first 12 postoperaive hour
Measured: First 12 hour from arriving at postoperative recovery
Secondary outcomes (4)
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
Measured: First 12 hour from arriving at postoperative recovery
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
Measured: First 24 hour from arriving at postoperative recovery
Incidence of Acute block complication - based on clinical assessment
pneumothorax, local anesthetic toxicity, epidural spread, bleeding
Measured: First 12 hour since block placement
Incidence of Delayed block complication - based on clinical assessment
paresthesia, motor weakness, hematoma, abscess
Measured: First 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Lin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294315
- Sponsor's protocol ID
- 120374
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study
- ClinicalTrials.gov ID
- NCT05294315
- Acronym / sponsor ID
- 120374
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single level block arm - Control | Active comparator | Procedure: Single level erector spinae blockSingle level erector spinae block at 4th transverse process |
| Bi-level block arm - Intervention | Experimental | Procedure: Bi-level erector spinae blockBi-level erector spinae block at 4th and 6th transverse process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (at least 18 years old)
- elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-level erector spinae blockerector spinae block at 4th and 6th transverse process | Procedure or surgery | Bi-level block arm - Intervention |
| Single level erector spinae blockerector spinae block at 4th transverse process | Procedure or surgery | Single level block arm - Control |
Primary outcome
Opioid use in first 12 postoperaive hour
Time frame: First 12 hour from arriving at postoperative recovery
4 secondary outcomes
Pain score area under curve first 12 hour
Time frame: First 12 hour from arriving at postoperative recovery
Pain score area under curve first 24 hour
Time frame: First 24 hour from arriving at postoperative recovery
Incidence of Acute block complication - based on clinical assessment
Time frame: First 12 hour since block placement
Incidence of Delayed block complication - based on clinical assessment
Time frame: First 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-level erector spinae block and Single level erector spinae block in people with Acute Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Lin (5197025758, cheng.lin@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use in first 12 postoperaive hour (time frame: First 12 hour from arriving at postoperative recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.