Thoracolumbar Block for Spinal Fusion Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for managing pain in older adults undergoing spinal fusion surgery. It employs a special anesthesia technique called a Thoracolumbar Interfascial Plane (TLIP) block, similar to a numbing shot given to the back during surgery, to determine its effectiveness in reducing pain and other postoperative issues. The study will also assess patient recruitment and trial completion, with the goal of planning a larger study in the future. Suitable candidates are those aged 65 or older, planning specific back surgery, without severe heart or lung problems, and without existing severe cognitive issues. As an Early Phase 1 trial, this research aims to understand how the TLIP block works in people, offering participants the opportunity to be among the first to benefit from this innovative pain management approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are opioid tolerant (taking more than 60 mg of morphine equivalent per day), you may not be eligible to participate.
What prior data suggests that the TLIP block is safe for spinal fusion recovery?
Research has shown that TLIP blocks with bupivacaine can help manage pain after spinal surgery. In studies, patients who received TLIP blocks reported less pain and required fewer pain medications post-surgery. This suggests that the treatment is generally well-tolerated by those undergoing spinal surgery.
The TLIP block also aids in recovery. Patients often report better pain relief and higher satisfaction with their recovery process. Some studies indicate that patients experience fewer side effects compared to those who do not receive the block.
These findings suggest that TLIP blocks might be a safe option for managing pain in spinal fusion surgeries. However, as this trial is in an early stage, gathering more data to confirm these results remains important.12345Why are researchers excited about this trial?
Researchers are excited about the Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine because it offers a new approach to enhancing recovery after spinal fusion surgery. Unlike typical treatments that rely solely on standard anesthesia, this technique involves administering a local anesthetic directly to the thoracolumbar area, potentially improving pain management and reducing the need for additional pain medications post-surgery. This targeted delivery method not only aims to provide more effective pain relief but also minimizes systemic side effects, which is a significant advantage over conventional anesthesia options.
What evidence suggests that the TLIP block is effective for spinal fusion recovery?
This trial will compare the effectiveness of thoracolumbar interfascial plane (TLIP) blocks with standard anesthesia in managing pain after spinal fusion surgery. Studies have shown that TLIP blocks effectively manage pain following spinal surgeries. Patients receiving TLIP blocks report less pain both at rest and during movement for up to 24 hours and often require fewer pain medications post-surgery. Research indicates that patients experience better recovery, with improved pain levels and overall quality of recovery. This suggests that TLIP blocks could be a promising option for managing pain after spinal fusion surgery.23678
Who Is on the Research Team?
Catherine R Olinger, MD
Principal Investigator
Clinical Assistant Professor
Are You a Good Fit for This Trial?
This trial is for adults aged 65 or older who need lumbar spinal fusion surgery of up to three levels and have no severe heart, lung diseases, cognitive dysfunction, or allergies to local anesthetics. It's not for those with major liver/kidney issues, opioid tolerance, other chronic pain conditions, significant neurological deficits, psychiatric illnesses, under age 65, pregnant/breastfeeding women or those with a high BMI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care anesthesia with or without TLIP Block of bupivacaine during spinal fusion surgery
Post-operative Monitoring
Participants are monitored for changes in pain, opioid use, and other health outcomes immediately after surgery and at various intervals up to 12 weeks post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 90-day readmission rates and disposition to skilled facilities
What Are the Treatments Tested in This Trial?
Interventions
- Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Iowa
Lead Sponsor