Pain, Postoperative, Spine Fusion, Surgery
Conditions
Brief summary
Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.
Detailed description
For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.
Interventions
DRUG0.25% Marcaine at 2ml/hr and pain medications
Subcutaneous pain control with OnQ Subcutaneous Drug pump
DEVICEPlacement of OnQ Drug pump
Subcutaneous placement of OnQ drug pump with normal saline infusion
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This trial is a comparative trial investigating outcomes in 3 parallel groups. The control group will receive standard of care pain control following surgery, the Marcaine group will receive infusion of FDA approved Marcaine around the operative site following surgery through an FDA approved surgical device. The Placebo group will have the drug delivery device implanted with delivery of saline.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient 18 years of age or greater * Surgery to be done at Banner University Medical Center-Tucson * Elective Surgeries only * Lower Thoracic or Lumbar fusions only - Posterior Approach * Postero or Posterolateral Instrumented Fusions with or without Interbody graft * Transforaminal Interbody Fusions * Must be able to cooperate in the daily VAS assessment
Exclusion criteria
* Patients under 18 years of age * Prisoners * Pregnant women * Hypersensitivity to infusion medication * Deformity Correction cases requiring osteotomies * Surgical fusion in acute phase for traumatic injury * Anterior Lumbar Interbody Fusion, Direct Lateral Interbody Fusion procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain control | From post operative day 1 until patient discharge or 30 days, whichever comes first | A daily Visual Analog Score Pain scale (1-10) for pain severity, (1 least pain, 10 most pain) will be assessed and recorded daily by a blinded assessor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first. | Number of hospital days from time when patient surgery is completed to discharge will be assessed |
| Total Milligrams of IV pain medication | from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first | Total milligrams of IV pain medications will be assessed |
| Total Doses of IV pain medication | from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first | Number of doses of IV pain medications will be assessed |
| Total Milligrams of oral pain medication | from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first | Total milligrams of oral pain medications will be assessed |
| Total Doses of oral pain medication | from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first | Total doses of oral pain medications will be assessed |
Countries
United States
Outcome results
None listed