Pre-op vs Intra-op TLIP for Spinal Fusion

Overseen By Grace SanAgustin, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must not be taking: Cocaine, THC

Disqualifiers: Under 18, Revision surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of pain relief for individuals undergoing spinal fusion surgery. It compares a preoperative pain block using an ultrasound (Preoperative Ultrasound TLIP) to an intraoperative pain block under direct view (Intraoperative TLIP). The goal is to determine which method more effectively manages pain. Individuals requiring spinal fusion who do not heavily use opioids daily may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your daily morphine milligram equivalent (MME) is less than 25 MME per day before the operation. If you are taking medications that affect this, you may need to adjust them.

What prior data suggests that these techniques are safe for spinal fusion?

Research shows that both preoperative ultrasound TLIP and intraoperative TLIP treatments are generally safe for patients undergoing spinal fusion surgery.

For the preoperative ultrasound TLIP, studies have found that a similar method, TLIF, can be performed safely and effectively treats lower back disc issues with minimal risk.

Similarly, research on intraoperative TLIP confirms its safety and effectiveness, even for those with previous back surgeries. It yields good results and is well-tolerated.

In both treatments, serious side effects are rare, and complications are uncommon. Participants in the trial can expect a generally safe experience with either treatment method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing preoperative and intraoperative TLIP techniques for spinal fusion because it explores two innovative ways to manage pain. Unlike traditional methods that often rely on systemic pain medications, these techniques use ropivacaine, a local anesthetic, directly at the site of surgery. The preoperative approach employs ultrasound guidance for precision, potentially reducing pain and improving recovery times before surgery even begins. Meanwhile, the intraoperative method applies the anesthetic during surgery, allowing for direct visualization, which could enhance the effectiveness of pain relief right at the time it is most needed. This trial could lead to more targeted, efficient pain management strategies, reducing reliance on opioids and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for spinal fusion?

Research shows that transforaminal lumbar interbody fusion (TLIF) effectively treats spine issues like lumbar disc problems. Studies have found that a minimally invasive TLIF approach can lead to successful spine fusion and fewer complications after surgery. In this trial, participants will be divided into two groups: the Preoperative Ultrasound TLIP Group and the Intraoperative TLIP Group. Research indicates that Preoperative Ultrasound TLIP aids surgical success and patient recovery. Similarly, evidence for Intraoperative TLIP shows positive results, including high fusion rates and improved quality of life after surgery. Both methods have shown promise in improving surgical outcomes and aiding recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Daniel Park, MD

Principal Investigator

William Beaumont Hospitals

Are You a Good Fit for This Trial?

This trial is for adults over 18 needing a specific back surgery (1-3 level posterior laminectomy with fusion) and taking low doses of pain medication. They must agree to follow the study plan and attend check-ups after surgery. People under 18, not consenting, requiring revision surgery, using certain drugs, or involved in lawsuits can't join.

Inclusion Criteria

I take less than 25 MME of pain medication daily before surgery.

Compliant with study requirements and outpatient follow-up

I need a specific spine surgery involving 1 to 3 levels.

Exclusion Criteria

Ongoing lawsuits, workers compensation, and litigation will be excluded.

A positive drug screen for cocaine and/or tetrahydrocannabinol (THC), defined in the standard Corewell Drugs of Abuse Screening as cocaine > 300 ng/mL and cannabinoid > 50 ng/mL-any

I take less than 25 MME of pain medication daily before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Demographics and medical history are collected, and participants are stratified based on age and gender

1 week

Treatment

Participants undergo 1-3 level posterior lumbar laminectomy and fusion procedure with either pre-op or intra-op TLIP block

Surgery day

1 visit (in-person)

Postoperative Monitoring

Pain and opioid analgesia are assessed using VAS and Likert scales at various intervals post-surgery

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction and adverse events

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative TLIP
• Preoperative Ultrasound TLIP

Trial Overview The study compares two timing approaches for administering TLIP anesthesia: one before surgery (Pre-op) and another during the operation (Intra-op). It's designed to see which method works better for pain management in spinal fusion patients.

How Is the Trial Designed?

Group I: Preoperative Ultrasound TLIP Group Active Control 1 Intervention

Participant will receive TLIP in preop with 20cc of 0.2% ropivacaine administered bilaterally, 40cc total. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator.

Group II: Intraoperative TLIP Group Active Control 1 Intervention

Participants will receive TLIP with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks will be performed intraoperatively under direct surgical visualization.

Intraoperative TLIP is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

Approved in European Union as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Scoliosis

Approved in Canada as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

Approved in Japan as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Published Research Related to This Trial

In a study of 36 patients with persistent low back pain after failed PLIF or TLIF surgeries, salvage anterior lumbar interbody fusion (ALIF) was performed, showing it to be a safe and effective option for improving pain and achieving spinal stability.

The study found that 83.3% of patients required additional posterior surgery, but ALIF significantly improved clinical outcomes, including pain relief and spinal alignment, with no major intraoperative complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful salvage strategy using anterior retroperitoneal approach in failed posterior lumbar interbody fusion. A retrospective analisys on lumbar lordosis and clinical outcome. Bassani, R., Morselli, C., Cirullo, A., et al.[2022]

In a study of 1363 patients who underwent PLIF/TLIF, 2.8% required reoperation within 2 years, with common reasons including adjacent segment degeneration and surgical site infections.

The analysis revealed that fusing two or more levels during surgery significantly increased the risk of reoperation, highlighting the importance of surgical invasiveness and complications like dural tears and prolonged operation time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reoperation within 2 years after lumbar interbody fusion: a multicenter study. Kobayashi, K., Ando, K., Kato, F., et al.[2021]

In a study of 96 patients with lumbar disc herniation and spinal stenosis, both posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) showed similar improvements in pain and quality of life after surgery.

However, PLIF was associated with shorter operation times and less intraoperative blood loss compared to TLIF, suggesting it may be the preferred surgical option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of PLIF and TLIF in the Treatment of LDH Complicated with Spinal Stenosis. Fang, X., Zhang, M., Wang, L., et al.[2022]

In a study of 226 patients undergoing surgery for degenerative lumbar spondylolisthesis, the transforaminal lumbar interbody fusion (TLIF) technique showed significantly lower rates of postoperative complications, such as nerve root injuries and dural tears, compared to the posterior lumbar interbody fusion (PLIF) technique.

Both PLIF and TLIF resulted in similar short-term functional outcomes, but PLIF was associated with higher operative times, blood loss, and re-operation rates, suggesting that TLIF may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of perioperative complications between transforaminal versus posterior lumbar interbody fusion in degenerative lumbar spondylolisthesis. Liu, J., Deng, H., Long, X., et al.[2022]

Both PLIF and TLIF procedures effectively reduce back and leg pain, restore lumbar spine alignment, and achieve high fusion rates with good long-term stability, making them reliable options for lumbar interbody fusion.

The TLIF procedure offers additional benefits over PLIF, including shorter surgery times, reduced blood loss, and lower risk of nerve injury, making it particularly suitable for single-sided pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The PLIF and TLIF techniques. Indication, technique, advantages, and disadvantages]. Fleege, C., Rickert, M., Rauschmann, M.[2018]

This study aims to compare the clinical outcomes and complications of two surgical techniques, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), in treating adult lumbar spondylolisthesis over a 1-year follow-up period.

The research will analyze patients treated at a single center from July 2016 to February 2019, focusing on functional outcomes, complications, and radiographic results, providing valuable insights into which surgical approach may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective controlled study protocol of transforaminal lumbar interbody fusion compared with posterior lumbar interbody fusion for spondylolisthesis. Yi, P., Tang, X., Yang, F., et al.[2022]

In a biomechanical study of 10 lumbar spinal segments, it was found that intervertebral cages absorb more than 50% of the axial load when posterior instrumentation is not used, indicating a significant load-sharing role of the cages in spinal fusion procedures.

When posterior instrumentation is added, the external load on the cages decreases significantly, suggesting that this instrumentation helps distribute the compression forces more evenly, reducing stress on the pedicle screws and rods in the spinal construct.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Load distribution on intervertebral cages with and without posterior instrumentation. Calek, AK., Cornaz, F., Suter, M., et al.[2023]

The TLIF procedure provides similar biomechanical stability to the PLIF procedure, with both showing reduced range of motion compared to an intact lumbar segment, but with no significant differences between the two methods.

While TLIF reduces stress at the cage-endplate interface compared to PLIF, it does result in a 70.7% increase in stress on the pedicle screws during flexion, suggesting a trade-off in screw stability that may need to be considered clinically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of posterior lumbar interbody fusion and transforaminal lumbar interbody fusion by finite element analysis. Xu, H., Tang, H., Guan, X., et al.[2013]

Transforaminal lumbar interbody fusion (TLIF) is associated with shorter surgical times and less blood loss compared to posterior lumbar interbody fusion (PLIF) in treating symptomatic lumbar instability, based on a study of 102 patients with a minimum follow-up of one year.

Both TLIF and PLIF effectively improve pain and functional outcomes, but TLIF shows a lower rate of complications, making it a preferable option for patients with lumbar instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the early results of transforaminal lumbar interbody fusion and posterior lumbar interbody fusion in symptomatic lumbar instability. Sakeb, N., Ahsan, K.[2022]

Transforaminal lumbar interbody fusion (TLIF) offers significant advantages over posterior lumbar interbody fusion (PLIF), including a lower risk of neurological injury and better spinal alignment due to graft placement in the anterior column.

Both PLIF and TLIF benefit from advancements in grafting materials and techniques, which enhance fusion rates, particularly when using posterior pedicle screw-rod constructs and osteoinductive materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. Cole, CD., McCall, TD., Schmidt, MH., et al.[2022]

Citations

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Quality-of-Life Outcomes With Minimally Invasive ... There were statistically significant clinical outcomes after MITLIF surgery, including spinal fusion and decreased postoperative complications. Keywords: lumbar ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590139725000523

Outpatient transforaminal lumbar interbody fusion ... Beyond safety, the outpatient TLIF group underwent statistically favorable operations and outcomes. The results likely suggest that the outpatient group had a ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05315-5

Comparative efficacy and fusion outcomes of unilateral bi ... Fusion rates at 2 years postoperatively were identical, including 95% for the UBE-TLIF group and 97.7% for the MIS-TLIF group. However, compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7859762/

Narrative review of intraoperative image guidance for ... More recent data have shown continued growth, with a 137% increase in the rate of lumbar fusion from 1998 to 2008, significantly outpacing the growth in total ...

5. nature.com nature.com/articles/s41598-024-81402-1

Comparison of clinical and radiologic outcomes between ... Compared to PLIF, BE-TLIF showed similarly good clinical and radiologic outcomes, with better results in terms of early postoperative outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25527402/

Effectiveness and safety of transforaminal lumbar interbody ... The current study confirmed that TLIF approach in patients with previous laminectomy is effective and safe with good outcomes.

7. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1598531/full

The safety and effectiveness of transforaminal lumbar ... This study aims to evaluate the safety and effectiveness of transforaminal lumbar interbody fusion surgery for the treatment of lumbar disc herniation.

8. ijssurgery.com ijssurgery.com/content/early/2025/04/17/8753

Safety and Viability of Anterior Lumbar Interbody Fusion in ... Conclusion ALIF is a safe and effective option for revision surgeries involving TLIF/PLIF cage removal, offering a low complication profile and ...