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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615939
Recruitment Status : Terminated (The study has been terminiated due to minimal subject recruitment)
First Posted : June 11, 2012
Results First Posted : June 30, 2016
Last Update Posted : August 1, 2016
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Fracture of Foot Drug: Bupivacaine Drug: Ropivacaine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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).
Drug: Bupivacaine
Bupivacaine 0.625% with epinephrine 1:300,000
Other Name: Sensorcaine

Active Comparator: 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.
Drug: Ropivacaine
0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
Other Name: Naropin

Primary Outcome Measures :
  1. Temporary Neurologic Symptoms Between Groups [ Time Frame: 1 month ]
    Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion

Secondary Outcome Measures :
  1. Participant Satisfaction With Anesthesia [ Time Frame: 24 hours ]
    Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied

  2. Pain Control [ Time Frame: 72 hrs ]
    Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615939

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine

Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University Identifier: NCT01615939     History of Changes
Other Study ID Numbers: STU00058306
First Posted: June 11, 2012    Key Record Dates
Results First Posted: June 30, 2016
Last Update Posted: August 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Antoun Nader, Northwestern University:
Sciatic Nerve Block
Continuous Nerve Block

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents