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Local Anesthetic

Fentanyl for Post-Laminectomy Syndrome

Phase 4
Waitlist Available
Led By Salim Hayek, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights

Summary

This trial will study whether an intrathecal infusion test can help predict which patients will have better long-term outcomes from an implantable device for chronic low back pain.

Eligible Conditions
  • Post-Laminectomy Syndrome
  • Chronic Lower Back Pain
  • Vertebral Compression Fractures
  • Back Surgery Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Numerical Rating Scale Pain Scores (NRS) With Activity
Change in Numerical Rating Scale Pain Scores (NRS) at Rest
Secondary study objectives
Adverse Event (AE)
Change in Medication
Change in Oswestry Disability Score (ODI)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Solution followed by Inactive Placebo SolutionActive Control5 Interventions
Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml 6 hour washout followed by Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline
Group II: Inactive Placebo Solution followed by Active SolutionPlacebo Group5 Interventions
Continuous intrathecal prognostic infusion test of inactive placebo solution: preservative-free normal saline 6 hour washout followed by Continuous intrathecal prognostic infusion test of active solution: intrathecal bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml

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Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
320 Previous Clinical Trials
339,952 Total Patients Enrolled
Salim Hayek, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
3 Previous Clinical Trials
3,549 Total Patients Enrolled
~5 spots leftby Sep 2025
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