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

Lumbar Spine Degeneration Clinical Trial

— Exparel  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644796
• Other study ID #: 2037544
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lumbar Spine Degeneration

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Anes — View Citation

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 — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Utilization	Comparing post operative opioid usage reduction between treatment and placebo group.	Until final follow-up, up to 8 weeks.
Secondary	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.
Secondary	Length of Stay	Determining how long patient is in hospital.	Until final follow-up, up to 8 weeks.
Secondary	Operative Data and Complications	Comparing intraoperative complications, acute postoperative complication, and opioid complications.	Until final follow-up, up to 8 weeks.

External Links

•   Drug Overdose Epidemic Data
•   Exparel dosage guidelines