Back to resultsPostoperative subQ Pain Control for Spinal Fusion Surgery
Primary Purpose
Spine Fusion, Surgery, Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.25% Marcaine at 2ml/hr and pain medications
Placement of OnQ Drug pump
Sponsored by
About this trial
This is an interventional treatment trial for Spine Fusion
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
Sites / Locations
- The University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Placebo Comparator
Arm Label
Control Group
Marciano Group
Placebo Group
Arm Description
Normal treatment paradigm (no anesthetic pump) with pain medications, only.
Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.
OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to discharge
Number of hospital days from time when patient surgery is completed to discharge will be assessed
Total Milligrams of IV pain medication
Total milligrams of IV pain medications will be assessed
Total Doses of IV pain medication
Number of doses of IV pain medications will be assessed
Total Milligrams of oral pain medication
Total milligrams of oral pain medications will be assessed
Total Doses of oral pain medication
Total doses of oral pain medications will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03476811
Brief Title
Postoperative subQ Pain Control for Spinal Fusion Surgery
Official Title
Postoperative subQ Pain Control for Spinal Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Fusion, Surgery, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Normal treatment paradigm (no anesthetic pump) with pain medications, only.
Arm Title
Marciano Group
Arm Type
Active Comparator
Arm Description
Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
Intervention Type
Drug
Intervention Name(s)
0.25% Marcaine at 2ml/hr and pain medications
Other Intervention Name(s)
OnQ Subcutaneous Drug pump
Intervention Description
Subcutaneous pain control with OnQ Subcutaneous Drug pump
Intervention Type
Device
Intervention Name(s)
Placement of OnQ Drug pump
Intervention Description
Subcutaneous placement of OnQ drug pump with normal saline infusion
Primary Outcome Measure Information:
Title
Pain control
Description
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.
Time Frame
From post operative day 1 until patient discharge or 30 days, whichever comes first
Secondary Outcome Measure Information:
Title
Time to discharge
Description
Number of hospital days from time when patient surgery is completed to discharge will be assessed
Time Frame
from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.
Title
Total Milligrams of IV pain medication
Description
Total milligrams of IV pain medications will be assessed
Time Frame
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
Title
Total Doses of IV pain medication
Description
Number of doses of IV pain medications will be assessed
Time Frame
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
Title
Total Milligrams of oral pain medication
Description
Total milligrams of oral pain medications will be assessed
Time Frame
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
Title
Total Doses of oral pain medication
Description
Total doses of oral pain medications will be assessed
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15220788
Citation
Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027.
Results Reference
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PubMed Identifier
11020770
Citation
Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
Results Reference
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PubMed Identifier
21102963
Citation
Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
Results Reference
background
PubMed Identifier
24436846
Citation
Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.
Results Reference
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Postoperative subQ Pain Control for Spinal Fusion Surgery
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