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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01615939
First received: June 7, 2012
Last updated: September 23, 2014
Last verified: September 2014

June 7, 2012
September 23, 2014
June 2012
June 2015   (final data collection date for primary outcome measure)
Temporary neurologic symptoms between groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01615939 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Foot Surgery
  • Drug: Bupivacaine
    Bupivacaine 0.625% with epinephrine 1:300,000
  • Drug: Ropivacaine
    0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
  • Active Comparator: Single Shot Sciatic Nerve Block
    Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty.
    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. 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.
 
Recruiting
580
Not Provided
June 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
No
Contact: Antoun Nader, MD 312/926-2280 a-nader2@northwestern.edu
United States
 
NCT01615939
STU00058306, STU00058306
No
Antoun Nader, Northwestern University
Northwestern University
Not Provided
Not Provided
Northwestern University
September 2014

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