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
  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
Foot Surgery
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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 580
Study Start Date: June 2012
Estimated Primary Completion Date: June 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.
Drug: Bupivacaine
Bupivacaine 0.625% with epinephrine 1:300,000
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.
Drug: Ropivacaine
0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

Contacts
Contact: Antoun Nader, MD 312/926-2280 a-nader2@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Antoun Nader, MD    312-926-2280    a-nader2@northwestern.edu   
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01615939     History of Changes
Other Study ID Numbers: STU00058306, STU00058306
Study First Received: June 7, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014