Postoperative subQ Pain Control for Spinal Fusion Surgery
- Conditions
- Spine FusionSurgeryPain, Postoperative
- Interventions
- Drug: 0.25% Marcaine at 2ml/hr and pain medicationsDevice: Placement of OnQ Drug pump
- Registration Number
- NCT03476811
- Lead Sponsor
- University of Arizona
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Marciano Group 0.25% Marcaine at 2ml/hr and pain medications Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications. Placebo Group Placement of OnQ Drug pump OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The University of Arizona
🇺🇸Tucson, Arizona, United States