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.
Overview
- Phase
- Phase 4
- Intervention
- saline 0.9%
- Conditions
- Lumbar Spine Degeneration
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Postoperative Opioid Utilization
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo Group
Patients in this group will be given the placebo (sterile saline).
Intervention: saline 0.9%
Liposomal bupivacaine
Patients in this group will be given the study drug (liposomal bupivacaine).
Intervention: Liposomal bupivacaine
Outcomes
Primary Outcomes
Postoperative Opioid Utilization
Time Frame: Until final follow-up, up to 8 weeks.
Comparing post operative opioid usage reduction between treatment and placebo group.
Secondary Outcomes
- Operative Data and Complications(Until final follow-up, up to 8 weeks.)
- Post Operative Pain Scores(Until final follow-up or up to 8 weeks after surgery date, whichever comes first.)
- Length of Stay(Until final follow-up, up to 8 weeks.)