Lumbar Spinal Stenosis study: Bupivacaine-Epinephrine vs Normal saline
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?
An investigational injectable medicine being studied to reduce postoperative opioid use in patients with lumbar spinal stenosis undergoing surgery. It is designed to block nerve signals and provide prolonged pain relief by combining a local anesthetic (bupivacaine) with epinephrine and clonidine.
Also referred to as bupivacaine, epinephrine, clonidine.
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
- The study aims to see whether adding regional pain‑relief techniques reduces the amount of opioids needed after common lumbar spine operations.
- Who it's for
- Adults scheduled for lumbar spinal surgery for conditions such as stenosis, disc herniation, spondylolisthesis, or related degenerative problems.
- What's involved
- Participants will receive a regional anesthetic block in addition to usual surgical care and will have regular pain and medication check‑ins after the operation.
- 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)
- 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)
- 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 is enrolling
- Chicago, Illinois, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.