Back to resultsPeri-Incisional Drug Injection in Lumbar Spine Surgery
Primary Purpose
Lumbar Disc Herniation, Degenerative Disc Disease, Spondylolisthesis
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Morphine
Epinephrine
naropin
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility 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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lumbar Spine Surgery with Injection
Lumbar Spine Surgery without Injection
Arm Description
Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.
Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery.
Outcomes
Primary Outcome Measures
Post-operative narcotic use
Secondary Outcome Measures
Patients' self-reported pain (CAPA) scores
Evaluates
intensity of pain
effect of pain on functionality
effect of pain on sleep
efficacy of therapy
progress toward comfort
Length of hospital stay
Full Information
NCT ID
NCT03513445
First Posted
April 12, 2018
Last Updated
August 16, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03513445
Brief Title
Peri-Incisional Drug Injection in Lumbar Spine Surgery
Official Title
Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Degenerative Disc Disease, Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar Spine Surgery with Injection
Arm Type
Experimental
Arm Description
Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.
Arm Title
Lumbar Spine Surgery without Injection
Arm Type
No Intervention
Arm Description
Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
Intervention Type
Drug
Intervention Name(s)
naropin
Intervention Description
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
Primary Outcome Measure Information:
Title
Post-operative narcotic use
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Patients' self-reported pain (CAPA) scores
Description
Evaluates
intensity of pain
effect of pain on functionality
effect of pain on sleep
efficacy of therapy
progress toward comfort
Time Frame
Up to 6 weeks
Title
Length of hospital stay
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Peri-Incisional Drug Injection in Lumbar Spine Surgery
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