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Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

NCT01167907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-08-31

Study results available
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Summary

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve.

The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters.

There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.

Conditions

  • Orthopedic Surgery of Lower Extremity

Interventions

DEVICE

0.2% ropivacaine

0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

DRUG

saline

saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

Sponsors & Collaborators

  • I-Flow

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Robert Weller, M.D. · Wake Forest Univesity Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-09-07
Completion
2017-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167907 on ClinicalTrials.gov