Peri-Incisional Drug Injection in Lumbar Spine Surgery

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03513445
• Other study ID #: ORSU-2018-26340
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Spondylolisthesis

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative narcotic use		Up to 6 weeks
Secondary	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
Secondary	Length of hospital stay		Up to 6 weeks