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NCT03523000 · ClinicalTrials.gov registry record · Phase 4
Determining the Prognostic Value of Continuous Intrathecal Infusion
A Phase 4 study of Chronic Low Back Pain and Vertebral Compression Fracture, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03523000 is a Phase 4 study of Chronic Low Back Pain and Vertebral Compression Fracture that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 36 participants, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03523000, a Phase 4 study of Chronic Low Back Pain and Vertebral Compression Fracture, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators will compare the primary outcomes \[changes in pain intensity score (NRS), patient global impression of change (PGIC)\] before and after intrathecal infusion of an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline. The study will include 36 patients with intractable chronic low back pain in the setting of lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative management and are considered candidates for IDDS. Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with an externalized catheter. Baseline NRS pain scores will be assessed and documented on all patients upon admission to the preoperative area. An intrathecal catheter will be placed in the outpatient procedure suite at the appropriate level for target dermatomes. The needle entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower thoracic spine, under local anesthesia with the patient awake and with minimal or no sedation. The intrathecal infusion will be started using an external pump once patient is in the PACU. The research component is to perform the intrathecal test with normal saline (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active solution). Patients will be randomly assigned to either Group I (continuous infusion of bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline followed by bupivacaine and fentanyl). In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the infusion. A
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bupivacaine
- DRUG Fentanyl
- OTHER Continuous intrathecal prognostic infusion test
- DEVICE Intrathecal Drug Delivery System (IDDS)
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03523000
The ClinicalTrials.gov registry entry for NCT03523000 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (94% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Chronic Low Back Pain appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03523000 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03523000 about?
NCT03523000 is a clinical study titled "Determining the Prognostic Value of Continuous Intrathecal Infusion". The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators wi...
What is the current status of trial NCT03523000?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2017-10-18. Estimated completion is 2021-10-12.
What conditions does trial NCT03523000 study?
This clinical trial studies the following conditions: Chronic Low Back Pain, Vertebral Compression Fracture, Failed Back Surgery Syndrome, Lumbar Post-Laminectomy Syndrome.
What interventions are being tested in trial NCT03523000?
The interventions under investigation include: Placebo (DRUG), Bupivacaine (DRUG), Fentanyl (DRUG), Continuous intrathecal prognostic infusion test (OTHER), Intrathecal Drug Delivery System (IDDS) (DEVICE).
Who is sponsoring clinical trial NCT03523000?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03523000 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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