NCT03513445

Peri-Incisional Drug Injection in Lumbar Spine Surgery

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-03-01
• Completion: 2022-09-01
• First posted: 2018-05-01
• Last updated: 2022-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study