Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(The study has been terminiated due to minimal subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01615939
First received: June 7, 2012
Last updated: June 29, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Fracture of Foot
Drug: Bupivacaine
Drug: Ropivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Temporary Neurologic Symptoms Between Groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion


Secondary Outcome Measures:
  • Participant Satisfaction With Anesthesia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied

  • Pain Control [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]
    Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable


Enrollment: 17
Study Start Date: June 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615939

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

Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01615939     History of Changes
Other Study ID Numbers: STU00058306 
Study First Received: June 7, 2012
Results First Received: May 23, 2016
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northwestern University:
Sciatic Nerve Block
Continuous Nerve Block

Additional relevant MeSH terms:
Ropivacaine
Bupivacaine
Epinephrine
Anesthetics, Local
Anesthetics
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 26, 2016