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

Northwestern University

Status and phase: Terminated; Phase 4

Conditions: Fracture of Foot

Treatments: Drug: Ropivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01615939

STU00058306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Single Shot Sciatic Nerve Block

Active Comparator group

Description:

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).

Treatment:

Drug: Bupivacaine

Continuous Sciatic Nerve Block

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine