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

NCT01615939 | Terminated Phase 4 Results

• 1 other identifier: STU00058306
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Foot

Keywords

Sciatic Nerve Block; Continuous Nerve Block

Outcome Measures

Primary Outcomes (1)

• Temporary Neurologic Symptoms Between Groups

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

  1 month

Secondary Outcomes (2)

• Participant Satisfaction With Anesthesia

  24 hours

• Pain Control

  72 hrs

Study Arms (2)

Single Shot Sciatic Nerve Block

ACTIVE COMPARATOR

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

Continuous Sciatic Nerve Block

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

Bupivacaine 0.625% with epinephrine 1:300,000

Also known as: Sensorcaine

Single Shot Sciatic Nerve Block

Ropivacaine DRUG

0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.

Also known as: Naropin

Continuous Sciatic Nerve Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Bupivacaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Antoun Nader
• Organization: Northwestern University, Feinberg School of Medicine

a-nader2@northwestern.edu

312-695-3045

Study Officials

• Antoun Nader, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 11, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 1, 2016
• Results First Posted: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)