A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.

Study Overview
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Brief Summary
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The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.

Detailed Description
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Multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. Many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. Liposomal bupivacaine (LB) (Exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. LB has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. The goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital stay.

Official Title
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A Randomized Controlled Trial of the Effect of Liposomal Bupivacaine (Exparel) When Compared to Saline Control in Reducing Opioid Utilization for Pain Management in Postoperative Lumbar Spine Surgeries.

Conditions
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Lumbar Spine Degeneration

Intervention / Treatment
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* Drug: saline 0.9%
* Drug: Liposomal bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing isolated lumbar spine procedures using a posterior approach. Surgical spine procedures include: Single-level lumbar spine surgeries with or without fusion Multi-level lumbar spine surgeries with or without fusion Exclusion Criteria: Procedures involving intrathecal space Patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine). Acute lumbar trauma that requires immediate spine stabilization Revision of failed back surgeries (including nonunion and malunion) Revision of wound or hardware Contraindication to regional anesthesia Patients with chronic use of opioid medications Liver dysfunction (INR > 1.5, albumin <2.8g/dl, bilirubin >2mg/dl) Renal dysfunction (eGFR < 60ml/min/1.73m2) Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation Unable to give informed consent Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Patients will be randomly assigned to either the treatment group or the placebo group. Patients in the study group will receive liposomal bupivacaine at the end of the procedure (following fascial closure, but prior to superficial closure), while patients in the placebo group will receive sterile saline. The injectate should be injected slowly and deeply, infusing  1-2 mL according to manufacture guidelines for infiltration. According to these guidelines, injection should utilize a moving needle technique (inject while withdrawing the needle) at multiple locations surrounding the incision(s) to achieve maximal effect. Care will be taken to aspirate prior to injection to minimize the risk of intravascular injection of medication.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Patients in this group will be given the placebo (sterile saline). | Drug: saline 0.9%<br>* Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.<br>* Other names: sterile saline;|
| Active Comparator: Liposomal bupivacaine<br>Patients in this group will be given the study drug (liposomal bupivacaine). | Drug: Liposomal bupivacaine<br>* Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Opioid Utilization | Comparing post operative opioid usage reduction between treatment and placebo group. | Until final follow-up, up to 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Scores | Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life. | Until final follow-up or up to 8 weeks after surgery date, whichever comes first. | 
| Length of Stay | Determining how long patient is in hospital. | Until final follow-up, up to 8 weeks. | 
| Operative Data and Complications | Comparing intraoperative complications, acute postoperative complication, and opioid complications. | Until final follow-up, up to 8 weeks. |