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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01615939
Other study ID # STU00058306
Secondary ID STU00058306
Status Terminated
Phase Phase 4
First received June 7, 2012
Last updated October 1, 2015
Start date June 2012
Est. completion date January 2015

Study information

Verified date October 2015
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
Bupivacaine 0.625% with epinephrine 1:300,000
Ropivacaine
0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.

Locations

Country Name City State
United States Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temporary neurologic symptoms between groups 1 month No
Secondary satisfaction with anesthesia 1 month No
Secondary pain control 24-72hrs, 2weeks, 4weeks No
See also
  Status Clinical Trial Phase
Completed NCT01229696 - Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia Phase 4
Completed NCT01049906 - Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery N/A
Terminated NCT05354791 - Pre-post Spinal Popliteal Block
Terminated NCT01325012 - Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters Phase 4
Enrolling by invitation NCT05425979 - Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks Phase 4
Completed NCT05368012 - MIDCAB (Mid-Calf Block) for Foot Surgery Phase 4
Enrolling by invitation NCT04575688 - Periarticular Injection Versus Popliteal Block Phase 4
Recruiting NCT01546077 - Placement of Perineural Catheters in the Popliteal Region Phase 4
Recruiting NCT06309381 - Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block.
Completed NCT04134962 - Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
Enrolling by invitation NCT04872322 - Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery Phase 3