AnesthesiaPhase 2/3NCT02479763
A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
A Phase 2/3 study testing Waveform-confirmed loss-of-resistance in people with Anesthesia, run by Montreal General Hospital at 2 sites in 2 countries.
Trial summary
In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Waveform-confirmed loss-of-resistance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35
Who cannot join
- adults who are unable to give their own consent
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
- allergy to local anesthetic (LA)
- pregnancy
- prior surgery in the thoracic spine
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Montreal General Hospital, McGill University
Montreal, Quebec, H3G 1A4
Thailand1 site
Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
Official title: A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.
- Conditions
- Anesthesia
- Being tested
- Waveform-confirmed loss-of-resistance
- Keywords
- Epidural waveform analysis, Loss of resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waveform-confirmed loss-of-resistanceProcedure or surgery
Using waveform analysis to confirm thoracic epidural space
| Study group | Role | What they receive |
|---|---|---|
| Conventional loss-of-resistance | No intervention | Not described |
| Waveform-confirmed loss-of-resistance | Experimental | Not described Receives: Procedure: Waveform-confirmed loss-of-resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Successful Epidural Blocks
Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.
Measured: up to 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De QH Tran, Montreal General Hospital
- Investigators
- De QH Tran, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479763
- Sponsor's protocol ID
- 15-077 MUHC
- Status last verified
- Jan 2016
- First submitted
- 22 Jun 2015
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
- ClinicalTrials.gov ID
- NCT02479763
- Acronym / sponsor ID
- 15-077 MUHC
- Conditions
- Anesthesia
- Keywords
- Epidural waveform analysis, Loss of resistance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional loss-of-resistance | No intervention | – |
| Waveform-confirmed loss-of-resistance | Experimental | Procedure: Waveform-confirmed loss-of-resistance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35
Key exclusion criteria (7 listed)
- adults who are unable to give their own consent
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
- allergy to local anesthetic (LA)
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 |
|---|---|---|
| Waveform-confirmed loss-of-resistanceUsing waveform analysis to confirm thoracic epidural space | Procedure or surgery | Waveform-confirmed loss-of-resistance |
Primary outcome
Percentage of Patients With Successful Epidural Blocks
Time frame: up to 15 minutes after the procedure
Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
De QH Tran principal investigator
McGill University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Waveform-confirmed loss-of-resistance in people with Anesthesia, run by Montreal General Hospital at 2 sites in 2 countries.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Thailand. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Successful Epidural Blocks (time frame: up to 15 minutes after the procedure). 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 22 Feb 2016.