Anesthesia
Conditions
Keywords
Epidural waveform analysis, Loss of resistance
Brief 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. 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.
Interventions
PROCEDUREWaveform-confirmed loss-of-resistance
Using waveform analysis to confirm thoracic epidural space
Sponsors
Montreal General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Successful Epidural Blocks | 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. |
Countries
Canada, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Loss-of-resistance Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space | 50 |
| Waveform-confirmed Loss-of-resistance Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Conventional Loss-of-resistance | Waveform-confirmed Loss-of-resistance | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 11 | 61.1 years STANDARD_DEVIATION 11.8 | 61.3 years STANDARD_DEVIATION 11.4 |
| American Society of Anesthesiologists (ASA) physical status, Categorical Class I; A normal healthy patient | 3 participants | 9 participants | 12 participants |
| American Society of Anesthesiologists (ASA) physical status, Categorical Class II; A patient with mild systemic disease | 21 participants | 23 participants | 44 participants |
| American Society of Anesthesiologists (ASA) physical status, Categorical Class III; A patient with severe systemic disease | 26 participants | 18 participants | 44 participants |
| BMI (kg/m^2), Continuous | 25.5 kg/m^2 STANDARD_DEVIATION 4.4 | 24.6 kg/m^2 STANDARD_DEVIATION 3.7 | 25.1 kg/m^2 STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 50 | 2 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: up to 15 minutes after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Loss-of-resistance | Percentage of Patients With Successful Epidural Blocks | 76 percentage of patients |
| Waveform-confirmed Loss-of-resistance | Percentage of Patients With Successful Epidural Blocks | 98 percentage of patients |