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Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

NCT02293525 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-01-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.

Conditions

  • Low Back Pain

Interventions

DEVICE

ReLeaf catheter

Continuous infusion rate 10ml/hr (5ml/side)

DRUG

Ropivacaine

DRUG

Saline

DRUG

Morphine

Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

DRUG

Oxycodone

10mg every 4-6 hours

Sponsors & Collaborators

  • Vital 5, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Primary Completion
2016-01-31
Completion
2016-01-31

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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 NCT02293525 on ClinicalTrials.gov