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Peri-Incisional Drug Injection in Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT03513445
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Degenerative Disc Disease Spondylolisthesis Drug: Morphine Drug: Epinephrine Drug: naropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: This is a single blind study in which participants are unaware of whether or not they received a peri-incisional injection of pain medication during their surgery.
Primary Purpose: Treatment
Official Title: Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Experimental: Lumbar Spine Surgery with Injection
Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.
Drug: Morphine
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Drug: Epinephrine
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Drug: naropin
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

No Intervention: Lumbar Spine Surgery without Injection
Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery.



Primary Outcome Measures :
  1. Post-operative narcotic use [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. Patients' self-reported pain (CAPA) scores [ Time Frame: Up to 6 weeks ]

    Evaluates

    • intensity of pain
    • effect of pain on functionality
    • effect of pain on sleep
    • efficacy of therapy
    • progress toward comfort

  2. Length of hospital stay [ Time Frame: Up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with comorbidities excluding use of proposed injection.
  • Patients with major head trauma such that they cannot provide consent or describe their post-operative pain.
  • Patients with other surgical treatment during study treatment (i.e. more than 1 surgery during the study period or within 30 days prior to surgery).
  • Pregnant women (as assessed by pre-operative pregnancy test, which is standard of care).
  • Patients with dementia such that they cannot provide consent or describe their post-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 to the pelvis, or with surgeries that cross the thoracolumbar junction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513445


Contacts
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Contact: Chris Martin, MD 612-273-8092 mart1865@umn.edu
Contact: Kristin Mathson, BA 612-273-8086 maths022@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Martin, MD    612-273-9400    mart1865@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03513445     History of Changes
Other Study ID Numbers: Study 2337
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Morphine
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents