Contrast and anesthetic levels for lumbar erector spinae plane block
Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy
NA · University Hospitals Cleveland Medical Center · NCT07174440
This trial will test whether injecting contrast dye and dexmedetomidine along with a local anesthetic during a lumbar erector spinae plane block improves numbness and reduces pain for adults having lumbar spinal fusion.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07174440 on ClinicalTrials.gov |
What this trial studies
Participants will receive an ultrasound-guided lumbar erector spinae plane block with a small catheter placed in the back; about one hour before surgery ropivacaine plus dexmedetomidine and iohexol contrast will be injected through the catheter. Investigators will map numbness using a quantitative sensory testing (QST) procedure and then remove the catheter after the surgical team obtains baseline CT images. Pain scores and opioid consumption will be recorded in the hospital over the four days after surgery. The protocol is conducted at a single center and excludes patients with prior lumbar surgery, significant renal or liver disease, certain drug allergies, high preoperative opioid use, pregnancy, or cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are adults 21–75 years old with ASA physical status I–III who can ambulate and are scheduled for a one- to three-level lumbar spine fusion without prior lumbar surgery.
Not a fit: Patients with prior lumbar surgery, metastatic spine disease, reduced kidney function (eGFR <60), active liver disease, allergies to the study drugs, high preoperative opioid use (≥30 mg morphine equivalent), pregnancy, or inability to report pain are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide better or longer-lasting postoperative pain relief after lumbar fusion and potentially reduce opioid use.
How similar studies have performed: Erector spinae plane blocks have shown benefit for postoperative spine pain in other studies, but using contrast dye together with dexmedetomidine in this setting is a relatively new approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range: Adult patients 21-75 years of age * ASA status: I-III * Planned lumbar spine fusion involving no more than three levels * Ability to ambulate prior to surgery Exclusion Criteria: * Previous lumbar spine surgery * Metastatic cancer with involvement of the lumbar spine * eGFR \< 60 mL/min/1.73m2 * Active liver disease (hepatitis or cirrhosis) * Confirmed allergy to ropivacaine, dexmedetomidine or iohexol * Cognitive impairment resulting in inability to rate pain scores * Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively * Pregnancy
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Salim Hayek, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Sena Ulucay, MD
- Email: Ayse.Ulucay@UHhospitals.org
- Phone: 216-84-3771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Spinal surgery, ESP block