Peri-Incisional Drug Injection in Lumbar Spine Surgery

Phase 3

Withdrawn

• Conditions: Degenerative Disc Disease; Lumbar Disc Herniation; Spondylolisthesis
• Interventions: Drug: Morphine; Drug: Epinephrine; Drug: naropin

• Registration Number: NCT03513445
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Study Start: 2018-06-01
• Primary Completion: 2022-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-19
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar Spine Surgery with Injection	Morphine	Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.
Lumbar Spine Surgery with Injection	naropin	Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.
Lumbar Spine Surgery with Injection	Epinephrine	Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery.

Primary Outcome Measures

Name	Time	Method
Post-operative narcotic use	Up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Patients' self-reported pain (CAPA) scores	Up to 6 weeks	Evaluates; * intensity of pain; * effect of pain on functionality; * effect of pain on sleep; * efficacy of therapy; * progress toward comfort
Length of hospital stay	Up to 6 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States