Trial Outcomes & Findings for A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block (NCT NCT01615939)
NCT ID: NCT01615939
Last Updated: 2016-08-01
Results Overview
Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
1 month
Results posted on
2016-08-01
Participant Flow
Participant milestones
| Measure |
Single Shot Sciatic Nerve Block
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Single Shot Sciatic Nerve Block
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
Baseline Characteristics
A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
Baseline characteristics by cohort
| Measure |
Single Shot Sciatic Nerve Block
n=8 Participants
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
n=4 Participants
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
48 years
n=99 Participants
|
41 years
n=107 Participants
|
41 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthTemporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion
Outcome measures
| Measure |
Single Shot Sciatic Nerve Block
n=8 Participants
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
n=4 Participants
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
|---|---|---|
|
Temporary Neurologic Symptoms Between Groups
|
0 percentage of total participants
|
0 percentage of total participants
|
SECONDARY outcome
Timeframe: 24 hoursPatient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied
Outcome measures
| Measure |
Single Shot Sciatic Nerve Block
n=8 Participants
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
n=4 Participants
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
|---|---|---|
|
Participant Satisfaction With Anesthesia
|
10 units on a scale
Interval 10.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: 72 hrsNumeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable
Outcome measures
| Measure |
Single Shot Sciatic Nerve Block
n=8 Participants
Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).
Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000
|
Continuous Sciatic Nerve Block
n=4 Participants
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.
Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
|
|---|---|---|
|
Pain Control
|
5 units on a scale
Interval 1.0 to 6.0
|
6 units on a scale
Interval 3.0 to 8.0
|
Adverse Events
Single Shot Sciatic Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Sciatic Nerve Block
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
Antoun Nader
Northwestern University, Feinberg School of Medicine
Phone: 312-695-3045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place