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

University of Missouri-Columbia34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lumbar Spine Degeneration

Interventions

saline 0.9%DRUG

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.

Liposomal bupivacaineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Missouri Orthopaedic Institute

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Postoperative Opioid Utilization

Comparing post operative opioid usage reduction between treatment and placebo group.

Time frame: Until final follow-up, up to 8 weeks.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Until final follow-up, up to 8 weeks.

Operative Data and Complications

Comparing intraoperative complications, acute postoperative complication, and opioid complications.

Time frame: Until final follow-up, up to 8 weeks.

Data from ClinicalTrials.gov

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