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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Single-center, randomized study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Study participants who are eligible for the posterior lumbar laminectomy and fusion procedure will be scheduled and also consented as a part of the study. Participants will be stratified based on age and gender to ensure equal distribution.

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 data supports the effectiveness of the treatment Intraoperative TLIP, Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF), Preoperative Ultrasound TLIP, Preoperative Ultrasound TLIP, Transforaminal Lumbar Interbody Fusion, TLIF?

The research indicates that both TLIF and PLIF are well-established procedures for spinal fusion, with TLIF offering advantages such as reduced risk of nerve injury and better alignment of the spine. These techniques have shown increased fusion rates, especially when combined with bone grafts and supportive hardware. ^{1 2 3 4 5}

Is TLIP for spinal fusion generally safe for humans?

Transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are well-established procedures for spinal fusion, but they can have complications that sometimes require additional surgery. While these procedures are popular and widely used, there is a risk of complications that may lead to reoperation within two years. ^{1 6 7 8 9}

How does the treatment Pre-op vs Intra-op TLIP for Spinal Fusion differ from other treatments for spinal fusion?

The Pre-op vs Intra-op TLIP for Spinal Fusion treatment is unique because it compares the timing of the TLIP procedure, either before (pre-op) or during (intra-op) surgery, which is not commonly addressed in standard spinal fusion techniques. This approach may offer insights into optimizing surgical outcomes and recovery by evaluating the benefits of preoperative ultrasound guidance versus traditional intraoperative methods. ^{1 3 4 5 10}

Research Team

Daniel Park, MD

Principal Investigator

William Beaumont Hospitals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Load distribution on intervertebral cages with and without posterior instrumentation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

A comparative study of perioperative complications between transforaminal versus posterior lumbar interbody fusion in degenerative lumbar spondylolisthesis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of PLIF and TLIF in the Treatment of LDH Complicated with Spinal Stenosis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[The PLIF and TLIF techniques. Indication, technique, advantages, and disadvantages]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of posterior lumbar interbody fusion and transforaminal lumbar interbody fusion by finite element analysis. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the early results of transforaminal lumbar interbody fusion and posterior lumbar interbody fusion in symptomatic lumbar instability. [2022]

8. Germany 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. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Reoperation within 2 years after lumbar interbody fusion: a multicenter study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A retrospective controlled study protocol of transforaminal lumbar interbody fusion compared with posterior lumbar interbody fusion for spondylolisthesis. [2022]