Thoracolumbar Block for Spinal Fusion Recovery
Palo Alto (17 mi)Overseen byCatherine R Olinger, MD
Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Iowa
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.
Is the treatment in the trial 'Thoracolumbar Block for Spinal Fusion Recovery' a promising treatment?Yes, the thoracolumbar block is a promising treatment for spinal fusion recovery. It can help reduce pain after surgery, decrease the need for painkillers, and improve recovery.12345
What safety data exists for the TLIP block in spinal fusion recovery?The TLIP block is described as a minimally invasive and relatively safe technique for postoperative analgesia in spine surgery. It has been evaluated in various studies, including systematic reviews, meta-analyses, and randomized controlled trials, which suggest it can reduce opioid requirements and enhance recovery. However, more clinical studies are needed to fully establish its safety profile.12345
What data supports the idea that Thoracolumbar Block for Spinal Fusion Recovery is an effective treatment?The available research shows that the Thoracolumbar Block, also known as TLIP Block, is effective in reducing pain after spine surgery. Studies indicate that patients who received this treatment needed less pain medication after their surgery, suggesting better pain control. Additionally, the treatment is described as safe and easy to perform, which can help patients recover more comfortably and quickly. Compared to other treatments, TLIP Block may offer a less invasive option with fewer side effects, making it a promising choice for managing pain after spinal surgery.12345
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are opioid tolerant (taking more than 60 mg/day of oral opioids), you cannot participate in the trial.
Eligibility Criteria
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
I am scheduled for a planned surgery.
I am recommended to have a spinal fusion surgery for up to 3 spine levels.
I do not have serious heart or lung conditions.
I am 65 years old or older.
I am not allergic to local anesthetics.
Exclusion Criteria
I take less than or equal to 60 mg/day of opioids.
I am 64 years old or younger.
I require immediate medical attention.
I have had a fracture caused by a medical condition.
I am looking to have a corrective surgery.
I have a psychiatric illness or a significant loss in my ability to move.
I have a blood disorder or a permanent clotting issue.
I require home oxygen or have significant brain or lung disease.
I have significant liver or kidney problems.
Treatment Details
The study tests the effectiveness of TLIP blocks using bupivacaine anesthesia in reducing post-operative pain and improving recovery in older adults after spinal fusion. It aims to assess feasibility for a larger trial by looking at recruitment rates and patient feedback on this pain management technique.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaineExperimental Treatment18 Interventions
Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.
Group II: Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.Active Control17 Interventions
Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of IowaIowa City, IA
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Who is running the clinical trial?
University of IowaLead Sponsor
References
Thoracolumbar Interfascial Plane Block for Spinal Cord Stimulator System Implantation: A Case Series. [2021]Thoracolumbar interfascial plane block (TLIPB) has recently been described for postoperative analgesia after thoracolumbar spine surgery. This block is minimally invasive, relatively safe, and easy to perform. TLIPB can potentially decrease opioid requirements and enhance recovery following spine surgery. We describe the sonoanatomic landmarks of this technique, and we report results of this retrospective case series on analgesic impact of this block in patients undergoing implantation of spinal cord stimulation systems. Clinical studies are required to investigate the analgesic role of TLIPB for spinal thoracolumbar surgery.
The Effect of the Modified Thoracolumbar Interfacial Nerve Plane Block on Postoperative Analgesia and Healing Quality in Patients Undergoing Lumbar Disk Surgery: A Prospective, Randomized Study. [2022]The purpose of this study was to investigate the effect of the modified thoracolumbar interfascial plane block (TLIP) on postoperative analgesia and quality of recovery in patients undergoing lumbar disk surgery.
Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. [2021]Thoracolumbar interfascial plane (TLIP) block has been discussed widely in spine surgery. The aim of our study is to evaluate analgesic efficacy and safety of TLIP block in spine surgery.
Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. [2021]Thoracolumbar interfascial plane (TLIP) block as a novel plane block technique was proposed in 2015 and can be performed in patients undergoing lumbar spine surgery. However, no meta-analysis demonstrates the effects of TLIP block on postoperative pain undergoing lumbar spine surgery.
Effect of Ultrasound-Guided Thoracolumbar Interfascial Plane Block on the Analgesic Requirements in Patients Undergoing Lumbar Spine Surgery Under General Anesthesia: A Randomized Controlled Trial. [2022]Thoracolumbar interfascial plane (TLIP) block was recently described as a regional anesthetic technique to achieve analgesia for lumbar spine surgery by blocking the dorsal rami of spinal nerves. The study aims to test the hypothesis that TLIP block can offer pain control and reduce the perioperative analgesic requirement in patients undergoing spinal surgery.