Clinical trial NCT03476811: Postoperative subQ Pain Control for Spinal Fusion Surgery
Official title: Postoperative subQ Pain Control for Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spine Fusion
Surgery
Pain, Postoperative
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain control
timeFrame: From post operative day 1 until patient discharge or 30 days, whichever comes first
Secondary outcomes:
measure: Time to discharge
timeFrame: from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.
measure: Total Milligrams of IV pain medication
timeFrame: 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
measure: Total Doses of IV pain medication
timeFrame: 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
measure: Total Milligrams of oral pain medication
timeFrame: 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
measure: Total Doses of oral pain medication
timeFrame: 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
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
Study officials:
References:
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.
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.
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.
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.