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New treatment option for Lumbar Spinal Stenosis
Official title Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
ClinicalTrials.gov ID: NCT05029726
What this study is testing
What is Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine?
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for lumbar spinal stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80
- Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS...
- Willing and able to give consent
You likely can't join if
- Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily...
- Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
- Known allergy to bupivacaine, clonidine or similar local anesthetics
- Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
- Chronic kidney disease (stage 3 or greater), or hepatic failure
- Active pregnancy
See the full eligibility criteria
- Age 18-80
- Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional...
- Willing and able to give consent
- Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
- Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
- Known allergy to bupivacaine, clonidine or similar local anesthetics
- Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
- Chronic kidney disease (stage 3 or greater), or hepatic failure
- Active pregnancy
- Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period
- Active Worker's Compensation litigation
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.