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

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.

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Degeneration
• Intervention / Treatment: Drug: saline 0.9%; Drug: Liposomal bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Missouri Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Patients in this group will be given the placebo (sterile saline).	Drug: saline 0.9%; 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.; Other Names: sterile saline
Active Comparator: Liposomal bupivacaine; Patients in this group will be given the study drug (liposomal bupivacaine).	Drug: Liposomal bupivacaine; 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.; Other Names: Exparel

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Theodore Choma, MD, University of Missouri - Missouri Orthopaedic Institute

Publications and helpful links

General Publications

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
• Butz DR, Shenaq DS, Rundell VL, Kepler B, Liederbach E, Thiel J, Pesce C, Murphy GS, Sisco M, Howard MA. Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2015 Jun 5;3(5):e391. doi: 10.1097/GOX.0000000000000355. eCollection 2015 May.
• Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.
• Grant GJ, Barenholz Y, Bolotin EM, Bansinath M, Turndorf H, Piskoun B, Davidson EM. A novel liposomal bupivacaine formulation to produce ultralong-acting analgesia. Anesthesiology. 2004 Jul;101(1):133-7. doi: 10.1097/00000542-200407000-00021.
• Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.

Helpful Links

• Drug Overdose Epidemic Data
• Exparel dosage guidelines

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2037544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes