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

Phase 4

Terminated

• Conditions: Fracture of Foot
• Interventions: Drug: Bupivacaine; Drug: Ropivacaine

• Registration Number: NCT01615939
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-05-23
• Results First Submitted QC: 2016-05-23
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Results First Posted: 2016-06-30
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Shot Sciatic Nerve Block	Bupivacaine	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).
Continuous Sciatic Nerve Block	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
Temporary Neurologic Symptoms Between Groups	1 month	Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction With Anesthesia	24 hours	Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied
Pain Control	72 hrs	Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States