Postoperative subQ Pain Control for Spinal Fusion Surgery

May 24, 2022 updated by: Robert Bina, University of Arizona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Normal treatment paradigm (no anesthetic pump) with pain medications, only.
Active Comparator: Marciano Group
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
Subcutaneous pain control with OnQ Subcutaneous Drug pump
Other Names:
  • OnQ Subcutaneous Drug pump
Placebo Comparator: Placebo Group
OnQ pump with placebo (normal saline at 2ml/hr) and pain medications.
Device: Placement of OnQ Drug pump
Subcutaneous placement of OnQ drug pump with normal saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From post operative day 1 until patient discharge or 30 days, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1712090332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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