Fracture of Foot
Conditions
Keywords
Sciatic Nerve Block, Continuous Nerve Block
Brief summary
The purpose of this study is to compare the incidence of postoperative symptoms of neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous infragluteal-parabiceps sciatic nerve catheter.
Detailed description
There are a limited number of prospective studies in the literature examining the risk of neurologic injury and symptoms after sciatic nerve blocks. The incidence of transient neurological symptoms after a continuous catheter is not well reported.
Interventions
DRUGBupivacaine
Bupivacaine 0.625% with epinephrine 1:300,000
DRUGRopivacaine
0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* all patients ( ≥18 and ≤ 80) who are scheduled to undergo elective scheduled foot surgery and agreed to receive a sciatic nerve catheter as a part of their postoperative pain management. this study.
Exclusion criteria
* history of hemostatic abnormalities * chronic pain syndrome * a foot deformity restricting normal foot movement * severe liver or renal disease * a preexisting neurologic disorder * patient refusal to participate * the presence of language barrier that prohibits proper communication with patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temporary Neurologic Symptoms Between Groups | 1 month | Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Anesthesia | 24 hours | Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied |
| Pain Control | 72 hrs | Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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. | 4 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
Baseline characteristics
| Characteristic | Continuous Sciatic Nerve Block | Single Shot Sciatic Nerve Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Continuous | 41 years | 48 years | 41 years |
| Region of Enrollment United States | 4 participants | 8 participants | 12 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
Primary
Temporary Neurologic Symptoms Between Groups
Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Shot Sciatic Nerve Block | Temporary Neurologic Symptoms Between Groups | 0 percentage of total participants |
| Continuous Sciatic Nerve Block | Temporary Neurologic Symptoms Between Groups | 0 percentage of total participants |
Secondary
Pain Control
Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable
Time frame: 72 hrs
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Sciatic Nerve Block | Pain Control | 5 units on a scale |
| Continuous Sciatic Nerve Block | Pain Control | 6 units on a scale |
Secondary
Participant Satisfaction With Anesthesia
Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Sciatic Nerve Block | Participant Satisfaction With Anesthesia | 10 units on a scale |
| Continuous Sciatic Nerve Block | Participant Satisfaction With Anesthesia | 10 units on a scale |