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

NCT04644796 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2037544
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Spine Degeneration

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Utilization

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

  Until final follow-up, up to 8 weeks.

Secondary Outcomes (3)

• 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.

• Operative Data and Complications

  Until final follow-up, up to 8 weeks.

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Patients in this group will be given the placebo (sterile saline).

Drug: saline 0.9%

Liposomal bupivacaine

ACTIVE COMPARATOR

Patients in this group will be given the study drug (liposomal bupivacaine).

Drug: Liposomal bupivacaine

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.

Also known as: sterile saline

Placebo Group

Liposomal bupivacaine DRUG

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.

Also known as: Exparel

Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

Location

Related Publications (5)

• 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.

  PMID: 26090281 RESULT

• 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.

  PMID: 24436846 RESULT

• 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.

  PMID: 15220782 RESULT

• 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.

  PMID: 25282071 RESULT

• 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.

  PMID: 22227789 RESULT

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Angela Atkinson
• Organization: Missouri Orthopaedic Institute

avadd9@umsystem.edu

573-884-1128

Study Officials

• Theodore Choma, MD

  University of Missouri - Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: February 10, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: June 13, 2023
• Results First Posted: January 4, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)