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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional loss-of-resistance | No Intervention | ||
| Waveform-confirmed loss-of-resistance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waveform-confirmed loss-of-resistance | Procedure | Using waveform analysis to confirm thoracic epidural space |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 15 minutes after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| De QH Tran | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital, McGill University | Montreal | Quebec | H3G 1A4 | Canada | ||
| Ramathibodi Hospital, Mahidol University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Loss-of-resistance | Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space |
| FG001 | Waveform-confirmed Loss-of-resistance | Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Loss-of-resistance | Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space |
| BG001 | Waveform-confirmed Loss-of-resistance | Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of patients | up to 15 minutes after the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Loss-of-resistance |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient self-resolving paresthesia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. De QH Tran | Montreal General Hospital | 514-934-1934 | 43261 | de_tran@hotmail.com |
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| Ratchathewi |
| Bangkok |
| 10400 |
| Thailand |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI (kg/m^2), Continuous | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) physical status, Categorical | The ASA physical status classification system is a system for assessing the fitness of patients before surgery. There are six classes depending on status of patients. While ASA class I is a normal healthy patient, ASA class VI is a declared brain-dead patient. | Number | participants |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| EG001 | Waveform-confirmed Loss-of-resistance | Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space | 0 | 50 | 2 | 50 |
| Vascular breach | Vascular disorders |
|
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