Skip to main content
Clinical Trials/NCT01615939
NCT01615939
Terminated
Phase 4

A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Northwestern University1 site in 1 country17 target enrollmentJune 2012

Overview

Phase
Phase 4
Intervention
Bupivacaine
Conditions
Fracture of Foot
Sponsor
Northwestern University
Enrollment
17
Locations
1
Primary Endpoint
Temporary Neurologic Symptoms Between Groups
Status
Terminated
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
January 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antoun Nader

Professor of Anesthesiology

Northwestern University

Eligibility 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.

Arms & Interventions

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: Bupivacaine

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: Ropivacaine

Outcomes

Primary Outcomes

Temporary Neurologic Symptoms Between Groups

Time Frame: 1 month

Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion

Secondary Outcomes

  • Pain Control(72 hrs)
  • Participant Satisfaction With Anesthesia(24 hours)

Study Sites (1)

Loading locations...

Similar Trials