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

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine	Liposomal bupivacaine	Patients in this group will be given the study drug (liposomal bupivacaine).
Placebo Group	saline 0.9%	Patients in this group will be given the placebo (sterile saline).

Primary Outcome Measures

Name	Time	Method
Postoperative Opioid Utilization	Until final follow-up, up to 8 weeks.	Comparing post operative opioid usage reduction between treatment and placebo group.

Secondary Outcome Measures

Name	Time	Method
Operative Data and Complications	Until final follow-up, up to 8 weeks.	Comparing intraoperative complications, acute postoperative complication, and opioid complications.
Post Operative Pain Scores	Until final follow-up or up to 8 weeks after surgery date, whichever comes first.	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.
Length of Stay	Until final follow-up, up to 8 weeks.	Determining how long patient is in hospital.