Peri-Incisional Drug Injection in Lumbar Spine Surgery

NCT03513445 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: ORSU-2018-26340
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation; Degenerative Disc Disease; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Post-operative narcotic use

  Up to 6 weeks

Secondary Outcomes (2)

• Patients' self-reported pain (CAPA) scores

  Up to 6 weeks

• Length of hospital stay

  Up to 6 weeks

Study Arms (2)

Lumbar Spine Surgery with Injection

EXPERIMENTAL

Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.

Drug: Morphine; Drug: Epinephrine; Drug: naropin

Lumbar Spine Surgery without Injection

NO INTERVENTION

Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery.

Interventions

Morphine DRUG

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

Lumbar Spine Surgery with Injection

Epinephrine DRUG

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

Lumbar Spine Surgery with Injection

naropin DRUG

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

Lumbar Spine Surgery with Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spondylolisthesis

Interventions

Morphine; Epinephrine; Ropivacaine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 1, 2018
• Study Start: June 1, 2018
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)