Peri-Incisional Drug Injection in Lumbar Spine Surgery

Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Disc Herniation; Degenerative Disc Disease; Spondylolisthesis
• Intervention / Treatment: Drug: Morphine; Drug: Epinephrine; Drug: naropin

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative narcotic use	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 6 weeks
Length of hospital stay		Up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spondylolisthesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Morphine; Epinephrine
• Other Study ID Numbers: ORSU-2018-26340

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