Postoperative subQ Pain Control for Spinal Fusion Surgery

NCT03476811 | Completed Phase 2 FDA Drug

• 1 other identifier: 1712090332
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Fusion; Surgery; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Control Group

NO INTERVENTION

Normal treatment paradigm (no anesthetic pump) with pain medications, only.

Marciano Group

ACTIVE COMPARATOR

Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications.

Drug: 0.25% Marcaine at 2ml/hr and pain medications

Placebo Group

PLACEBO COMPARATOR

OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.

Device: Placement of OnQ Drug pump

Interventions

0.25% Marcaine at 2ml/hr and pain medications DRUG

Subcutaneous pain control with OnQ Subcutaneous Drug pump

Also known as: OnQ Subcutaneous Drug pump

Marciano Group

Placement of OnQ Drug pump DEVICE

Subcutaneous placement of OnQ drug pump with normal saline infusion

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85724, United States

Location

Related 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. doi: 10.1097/00000542-200407000-00027.

  PMID: 15220788 BACKGROUND

• 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.

  PMID: 11020770 BACKGROUND

• 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.

  PMID: 21102963 BACKGROUND

• 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.

  PMID: 24436846 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery Resident

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 26, 2018
• Study Start: February 9, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)