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: May 23, 2016
Last verified: May 2016

June 7, 2012
May 23, 2016
June 2012
January 2015   (final data collection date for primary outcome measure)
Temporary Neurologic Symptoms Between Groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Temporary neurologic symptoms between groups; muscle weakness.
Temporary Neurologic Symptoms Between Groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01615939 on ClinicalTrials.gov Archive Site
  • 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
  • satisfaction with anesthesia [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Pain Control [ Time Frame: 24-72hrs, 2weeks, 4weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Fracture of Foot
  • Drug: Bupivacaine
    Bupivacaine 0.625% with epinephrine 1:300,000
    Other Name: Sensorcaine
  • Drug: Ropivacaine
    0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
    Other Name: Naropin
  • 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).
    Intervention: Drug: Bupivacaine
  • 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.
    Intervention: Drug: Ropivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
January 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01615939
STU00058306, STU00058306
No
No
Not Provided
Antoun Nader, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine
Northwestern University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP