Thoracolumbar Block for Spinal Fusion Recovery

Recruiting in Palo Alto (17 mi)

Overseen by Catherine R Olinger, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Iowa

Must not be taking: Opioids

Disqualifiers: Dementia, Liver dysfunction, Kidney dysfunction, others

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.

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 data supports the effectiveness of the treatment Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine for spinal fusion recovery?

Research shows that the TLIP block, which involves numbing specific nerves in the back, can help reduce pain and the need for pain medication after spine surgeries. This suggests it might be effective for recovery after spinal fusion as well. ^{1 2 3 4 5}

Is the Thoracolumbar Interfascial Plane (TLIP) Block safe for humans?

The Thoracolumbar Interfascial Plane (TLIP) Block is considered relatively safe and minimally invasive for use in spine surgeries, as noted in a case series. However, more clinical studies are needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the thoracolumbar block treatment differ from other treatments for spinal fusion recovery?

The thoracolumbar block is a unique treatment for spinal fusion recovery because it is a regional anesthetic technique that specifically targets the dorsal rami of spinal nerves to provide pain relief. This minimally invasive approach can reduce the need for opioids and enhance recovery, making it different from traditional pain management methods that often rely heavily on systemic medications. ^{1 2 3 4 5}

Research Team

Catherine R Olinger, MD

Principal Investigator

Clinical Assistant Professor

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.

Exclusion Criteria

I take less than or equal to 60 mg/day of opioids.

I have a chronic pain condition like fibromyalgia.

I am 64 years old or younger.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care anesthesia with or without TLIP Block of bupivacaine during spinal fusion surgery

1 day

1 visit (in-person)

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

12 weeks

Multiple visits (in-person and virtual) at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 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

16 months

Treatment Details

Interventions

• Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine (Local Anesthetic)

Trial Overview 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.

Participant Groups

Group I: Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine Experimental Treatment 18 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 Control 17 Interventions

Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Patients Recruited

934,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ozmen, O., Ince, I., Aksoy, M., et al.[2022]

The thoracolumbar interfascial plane (TLIP) block significantly reduces opioid consumption in the first 24 hours after spine surgery, with a mean difference of -16.00 mg compared to non-block care, based on a systematic review of 9 randomized controlled trials involving 539 patients.

TLIP block not only decreases the need for rescue analgesia and reduces postoperative nausea and vomiting, but it also outperforms wound infiltration in lowering opioid use, making it a more effective analgesic option for patients undergoing spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. Ye, Y., Bi, Y., Ma, J., et al.[2021]

The thoracolumbar interfascial plane (TLIP) block significantly reduced postoperative morphine consumption (5.13 mg vs. 14.33 mg) and delayed the first request for analgesia (7.30 hours vs. 0.92 hours) in patients undergoing lumbar spine surgery, indicating effective pain control.

Patients receiving the TLIP block also required less intraoperative fentanyl (15 mcgs vs. 105 mcgs) and experienced lower hemodynamic responses to surgical stimulation, suggesting that TLIP block enhances overall analgesic management during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Eltaher, E., Nasr, N., Abuelnaga, ME., et al.[2022]

The thoracolumbar interfascial plane (TLIP) block significantly reduces postoperative pain in patients undergoing lumbar spine surgery, as evidenced by lower visual analog scale (VAS) scores for pain at rest and during movement compared to those receiving patient-controlled analgesia (PCA) alone, based on a meta-analysis of 9 randomized controlled trials involving 618 patients.

Patients receiving the TLIP block also experienced lower PCA consumption and fewer nausea rates, indicating that this technique not only enhances pain management but also improves overall patient comfort after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. Hu, Z., Han, J., Jiao, B., et al.[2021]

The thoracolumbar interfascial plane block (TLIPB) is a minimally invasive and relatively safe technique that can provide effective postoperative analgesia after thoracolumbar spine surgery.

This block may reduce the need for opioids and improve recovery, although further clinical studies are needed to fully understand its analgesic benefits in spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracolumbar Interfascial Plane Block for Spinal Cord Stimulator System Implantation: A Case Series. Hoydonckx, Y., Kumar, P., Chin, KJ., et al.[2021]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

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]

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

Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

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]

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

Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. [2021]

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

Thoracolumbar Interfascial Plane Block for Spinal Cord Stimulator System Implantation: A Case Series. [2021]