Postoperative subQ Pain Control for Spinal Fusion Surgery

Surgery Clinical Trial

Official title:

Postoperative subQ Pain Control for Spinal Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476811
• Other study ID #: 1712090332
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Spine Fusion
• Surgery

Intervention

Drug:
• 0.25% Marcaine at 2ml/hr and pain medications
Subcutaneous pain control with OnQ Subcutaneous Drug pump

Device:
• Placement of OnQ Drug pump
Subcutaneous placement of OnQ drug pump with normal saline infusion

Locations

Country	Name	City	State
United States	The University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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