NCT03523000View on ClinicalTrials.gov

Determining the Prognostic Value of Continuous Intrathecal Infusion

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 18, 2017

Primary Completion Date

October 12, 2021

Study Completion Date

October 12, 2021

Conditions
Lumbar Post-Laminectomy SyndromeChronic Low Back PainVertebral Compression FractureFailed Back Surgery Syndrome
Interventions
OTHER

Continuous intrathecal prognostic infusion test

The patient is infused with solution through the percutaneous intrathecal catheter at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours

DRUG

Bupivacaine

Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours

DRUG

Fentanyl

Bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml continuous infusion at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours

DRUG

Placebo

Intrathecal infusion of normal saline at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours

DEVICE

Intrathecal Drug Delivery System (IDDS)

40-mL IDDS containing a solution of fentanyl 50 mcg/mL with bupivacaine 30 mg/mL

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
lead

University Hospitals Cleveland Medical Center

OTHER

NCT03523000 - Determining the Prognostic Value of Continuous Intrathecal Infusion | Biotech Hunter | Biotech Hunter