Trial Outcomes & Findings for A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks (NCT NCT02479763)
NCT ID: NCT02479763
Last Updated: 2016-02-22
Results Overview
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.
COMPLETED
PHASE2/PHASE3
106 participants
up to 15 minutes after the procedure
2016-02-22
Participant Flow
Participant milestones
| Measure |
Conventional Loss-of-resistance
Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
|
Waveform-confirmed Loss-of-resistance
Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
Baseline characteristics by cohort
| Measure |
Conventional Loss-of-resistance
n=50 Participants
Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
|
Waveform-confirmed Loss-of-resistance
n=50 Participants
Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
61.1 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
61.3 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
BMI (kg/m^2), Continuous
|
25.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=99 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 3.7 • n=107 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
American Society of Anesthesiologists (ASA) physical status, Categorical
Class I; A normal healthy patient
|
3 participants
n=99 Participants
|
9 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) physical status, Categorical
Class II; A patient with mild systemic disease
|
21 participants
n=99 Participants
|
23 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) physical status, Categorical
Class III; A patient with severe systemic disease
|
26 participants
n=99 Participants
|
18 participants
n=107 Participants
|
44 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 15 minutes after the procedureFifteen 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.
Outcome measures
| Measure |
Conventional Loss-of-resistance
n=50 Participants
|
Waveform-confirmed Loss-of-resistance
n=50 Participants
Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
|
|---|---|---|
|
Percentage of Patients With Successful Epidural Blocks
|
76 percentage of patients
|
98 percentage of patients
|
Adverse Events
Conventional Loss-of-resistance
Waveform-confirmed Loss-of-resistance
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Loss-of-resistance
n=50 participants at risk
|
Waveform-confirmed Loss-of-resistance
n=50 participants at risk
Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
|
|---|---|---|
|
Nervous system disorders
Transient self-resolving paresthesia
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Vascular breach
|
4.0%
2/50 • Number of events 2
|
0.00%
0/50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place