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Completed

NCT Number: NCT03476811

Postoperative subQ Pain Control for Spinal Fusion Surgery

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.

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Key information

Conditions

Spine Fusion Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.25% Marcaine at 2ml/hr and pain medications

Drug

Subcutaneous pain control with OnQ Subcutaneous Drug pump

Other names: OnQ Subcutaneous Drug pump

Placement of OnQ Drug pump

Device

Subcutaneous placement of OnQ drug pump with normal saline infusion

Primary outcomes

  1. Pain control

    Time frame: 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 outcomes

  1. Time to discharge

    Time frame: 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

  2. Total Milligrams of IV pain medication

    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

    Total milligrams of IV pain medications will be assessed

  3. Total Doses of IV pain medication

    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

    Number of doses of IV pain medications will be assessed

  4. Total Milligrams of oral pain medication

    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

    Total milligrams of oral pain medications will be assessed

  5. Total Doses of oral pain medication

    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

    Total doses of oral pain medications will be assessed

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2018
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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