A study on post surgical pain management

Official Title: A multicenter, prospective, active controlled, real world, Phase 4 study of EXPAREL in multimodal regimens compared with standard of care for postsurgical pain management in subjects undergoing lumbar posterior spine surgeries (FUSION)

Purpose:

The main purpose of this study is to compare total opioid consumption by patients in different treatment groups.

Another purpose of this study is to assess how well the study drug called EXPAREL is in reducing pain compared with current available standard of care treatments in adults undergoing lumbar posterior spine surgery. Additionally, this study will collect safety data and assess your satisfaction using the study drug. Please be aware that this informed consent form refers to EXPAREL as “study drug.”

There are 3 groups (also referred to as “cohorts”) in this spine study.
- Cohort 1 includes adults undergoing open lumbar posterior spinal fusion.
- Cohort 2 includes adults undergoing tubular or percutaneous without midline incision surgery and
- Cohort 3 includes adults undergoing lumbar decompression without fusion only surgery (also referred to as the “outpatient cohort”).

Eligibility criteria:

You may be eligible for this study if you are:

1) 18-75 years old at the time of screening
2) Scheduled for a posterior lumbar spine surgery (undergoing one of the following: Open Lumbar Posterior Spinal Fusion, Tubular without Midline Incision, Percutaneous without Midline Incision, or Lumbar Decompression without Fusion only) and will need medication to lessen pain.
3) Primary surgical indication is related to spinal degenerative disease, including any of the following:
a) Spinal stenosis
b) Spondylolisthesis
c) Radiculopathy/instability disc disorders
d) Degenerative disc disease
4) Scheduled to undergo:
a) Elective (i.e., not emergency)
b) Lumbosacral (i.e., L1-S1)
c) Posterior approach with posterior instrumentation

You will not qualify for the study if any of the following are true:

1) Have a serious spinal disease or condition, as determined by your doctor or including the following: suspected cauda equina syndrome (e.g., bowel/bladder involvement), infection, tumor, fracture, and/or systemic inflammatory spondyloarthropathy
2) History of severely impaired kidney or liver function
3) Severe chronic pain that requires analgesic treatment
4) Implanted spinal cord stimulator or intrathecal drug pump
5) Malignancy in the last 2 years
6) Have a history of misuse, abuse, or dependence on opioid medication, other prescription drugs, illicit drugs, or alcohol in the past 90 days
7) Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
8) Receiving Worker’s Compensation for disability or who are involved in other litigation related to the spine
9) Previous participation in an EXPAREL study

Other criteria will be reviewed by the study team.

Contact Information


Elizabeth Sheridan

Elizabeth.Sheridan@osumc.edu

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