A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Conditions
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Fracture of Foot

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Shot Sciatic Nerve Block<br>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). | Drug: Bupivacaine<br>* Bupivacaine 0.625% with epinephrine 1:300,000<br>* Other names: Sensorcaine;|
| Active Comparator: Continuous Sciatic Nerve Block<br>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. | Drug: Ropivacaine<br>* 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporary Neurologic Symptoms Between Groups | Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction With Anesthesia | Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied | 24 hours | 
| Pain Control | Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable | 72 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sciatic Nerve Block, Continuous Nerve Block