Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery

Study Overview
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Brief Summary
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The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery

Detailed Description
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Patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. Spine surgeons are looking for ways to reduce the pain that you experience. Anesthesiologists have introduced a procedure, called a TLIP block to provide pain relief. The block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. This block has been used by other surgeons for other types of surgeries in the past and has been shown to work. To determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared

Official Title
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Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing multilevel lumbar spine surgery, age 18-75 Exclusion Criteria: Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivicaine<br>Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine | Drug: Liposomal bupivacaine<br>* Use of liposomal bupivicaine as intraoperative local anesthesia<br>|
| Active Comparator: Bupivicane<br>Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000 | Drug: Bupivacaine Injection<br>* Use of bupivicaine as intraoperative local anesthesia<br>|
| Placebo Comparator: Placebo<br>Saline injection with 40mL preservative-free saline | Drug: Placebo<br>* Use of saline as placebo for local anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in postoperative pain | Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain | 24-48 hours | 
| Total postoperative opioid requirements | Using daily MME | 1-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented | 1-5 days | 
| Length of Hospital Stay | Number of postoperative days | 1-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, thoracolumbar, spine, pain