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

• ClinicalTrials.gov Identifier: NCT01615939
• Recruitment Status: Terminated
• First Posted: June 11, 2012
• Results First Posted: June 30, 2016
• Last Update Posted: August 1, 2016
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Antoun Nader, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fracture of Foot	Drug: Bupivacaine; Drug: Ropivacaine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Controlled Trial Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
• Study Start Date: June 2012
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	Drug: Bupivacaine; Bupivacaine 0.625% with epinephrine 1:300,000; Other Name: Sensorcaine
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 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.	Drug: Ropivacaine; 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.; Other Name: Naropin

Outcome Measures

Primary Outcome Measures :

1. Temporary Neurologic Symptoms Between Groups [ Time Frame: 1 month ]
   Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Antoun Nader, MD; Northwestern University Feinberg School of Medicine

More Information

• Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01615939
• Other Study ID Numbers: STU00058306; STU00058306
• First Posted: June 11, 2012
• Results First Posted: June 30, 2016
• Last Update Posted: August 1, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Antoun Nader, Northwestern University:

Sciatic Nerve Block; Continuous Nerve Block

Additional relevant MeSH terms:

Bupivacaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents