Peri-Incisional Drug Injection in Lumbar Spine Surgery

Last updated: August 16, 2022
Sponsor: University of Minnesota
Overall Status: Trial Not Available

Phase

3

Condition

Spondylolisthesis

Ankylosing Spondylitis

Radiculopathy

Treatment

N/A

Clinical Study ID

NCT03513445
ORSU-2018-26340
  • Ages > 18
  • All Genders

Study Summary

This is a randomized prospective study that will compare the use of narcotics in a control group of non-injected patients with a treatment arm of patients injected intra-operatively with a ropivacaine, morphine, and epinephrine cocktail. The investigators hypothesize that this treatment will reduce narcotic use in patients during their hospital stay, and possibly decrease the length of their stay in the hospital.The investigators also hope their pain will be decreased as displayed by their multi-daily Clinically Aligned Pain Assessment (CAPA) score.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any adult patient 18 years of age and older who is undergoing surgery for a lumbarspine problem. Common diagnoses in this category would include lumbar discherniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustivelist.

Exclusion

Exclusion Criteria:

  • Patients with comorbidities excluding use of proposed injection.
  • Patients with major head trauma such that they cannot provide consent or describetheir post-operative pain.
  • Patients with other surgical treatment during study treatment (i.e. more than 1surgery during the study period or within 30 days prior to surgery).
  • Pregnant women (as assessed by pre-operative pregnancy test, which is standard ofcare).
  • Patients with dementia such that they cannot provide consent or describe theirpost-operative pain.
  • Patients with an allergy to study medications.
  • Patients with previous drug dependencies.
  • Any patient that refuses to be randomized or does not wish to enroll.
  • Vulnerable populations, such as prisoners.
  • Patients with a fracture, tumor, or infection as their primary diagnosis.
  • Patients undergoing a deformity correction.
  • Patients with surgeries extending more than 4 levels, with surgeries that extend tothe pelvis, or with surgeries that cross the thoracolumbar junction.

Study Design

Study Start date:
June 01, 2018
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.