A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.
Condition: Lumbar Spine Degeneration
Intervention: saline 0.9%; Liposomal bupivacaine
Intervention description: 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.; 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.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Liposomal bupivacaine can be differentiated visually from normal saline. In order to blind the surgeons from treatment vs control, the syringes containing the medication or saline will be sheathed by the investigational drug study department.
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

Eligibility criteria:

        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