Trial Outcomes & Findings for Loss of Resistance, w/wo Stimulation, For Epidural Placement (NCT NCT03087604)
NCT ID: NCT03087604
Last Updated: 2020-06-17
Results Overview
will be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
15 minutes after administration of a test dose of lidocaine
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Traditional Technique Group
In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
|
Electric Stimulation Group
In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Loss of Resistance, w/wo Stimulation, For Epidural Placement
Baseline characteristics by cohort
| Measure |
Traditional Technique Group
n=50 Participants
In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
|
Electric Stimulation Group
n=50 Participants
In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after administration of a test dose of lidocainewill be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful.
Outcome measures
| Measure |
Traditional Technique Group
n=50 Participants
In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
|
Electric Stimulation Group
n=50 Participants
In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters
|
|---|---|---|
|
Success Rate of Placement of a Thoracic Epidural
|
41 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: From the initiation of procedure to end of procedureThe time required to place the epidural catheter will be recorded
Outcome measures
| Measure |
Traditional Technique Group
n=50 Participants
In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
|
Electric Stimulation Group
n=50 Participants
In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation
Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone.
Electrical Nerve stimulation: In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters
|
|---|---|---|
|
Time Required to Place the Epidural Catheter
|
33.9 minutes
Standard Deviation 12.8
|
24.0 minutes
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Thirty minutes after start of procedure.Population: No data collected
the number of thoracic spine levels attempted will be recorded
Outcome measures
Outcome data not reported
Adverse Events
Traditional Technique Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Electric Stimulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place