Postoperative subQ Pain Control for Spinal Fusion Surgery
Overview
- Phase
- Phase 2
- Intervention
- 0.25% Marcaine at 2ml/hr and pain medications
- Conditions
- Spine Fusion
- Sponsor
- University of Arizona
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Pain control
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Robert Bina
Neurosurgery Resident
University of Arizona
Eligibility Criteria
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
Arms & Interventions
Marciano Group
Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.
Intervention: 0.25% Marcaine at 2ml/hr and pain medications
Placebo Group
OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
Intervention: Placement of OnQ Drug pump
Outcomes
Primary Outcomes
Pain control
Time Frame: 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 Outcomes
- Time to discharge(from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.)
- 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 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)
- 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 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)