Postoperative subQ Pain Control for Spinal Fusion Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative subQ Pain Control for Spinal Fusion Surgery

Conditions
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Spine Fusion, Surgery, Pain, Postoperative

Intervention / Treatment
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* Drug: 0.25% Marcaine at 2ml/hr and pain medications
* Device: Placement of OnQ Drug pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Normal treatment paradigm (no anesthetic pump) with pain medications, only. | |
| Active Comparator: Marciano Group<br>Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications. | Drug: 0.25% Marcaine at 2ml/hr and pain medications<br>* Subcutaneous pain control with OnQ Subcutaneous Drug pump<br>* Other names: OnQ Subcutaneous Drug pump;|
| Placebo Comparator: Placebo Group<br>OnQ pump with placebo (normal saline at 2ml/hr) and pain medications. | Device: Placement of OnQ Drug pump<br>* Subcutaneous placement of OnQ drug pump with normal saline infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control | 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. | From post operative day 1 until patient discharge or 30 days, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | Number of hospital days from time when patient surgery is completed to discharge will be assessed | from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first. | 
| Total Milligrams of IV pain medication | Total milligrams of IV pain medications will be assessed | 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 Doses of IV pain medication | Number of doses of IV pain medications will be assessed | 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 oral pain medication | Total milligrams of oral pain medications will be assessed | 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 medication | Total doses of oral pain medications will be assessed | 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 |