Clinical trial NCT04644796: A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Spine Degeneration
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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
* Unable to give informed consent
* Pregnancy

Primary outcomes:
measure: Postoperative Opioid Utilization
timeFrame: Until final follow-up, up to 8 weeks.
Secondary outcomes:
measure: Post Operative Pain Scores
timeFrame: Until final follow-up or up to 8 weeks after surgery date, whichever comes first.
measure: Length of Stay
timeFrame: Until final follow-up, up to 8 weeks.
measure: Operative Data and Complications
timeFrame: Until final follow-up, up to 8 weeks.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri - Missouri Orthopaedic Institute
name: Theodore Choma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Jun 5;3(5):e391. doi: 10.1097/GOX.0000000000000355. eCollection 2015 May.
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. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.
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.
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.
citation: 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.