Peri-Incisional Drug Injection in Lumbar Spine Surgery

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 3

Conditions: Degenerative Disc Disease; Spondylolisthesis; Lumbar Disc Herniation

Treatments: Drug: Epinephrine; Drug: Morphine; Drug: naropin

Study type: Interventional

Funder types: Other

Identifiers

NCT03513445

ORSU-2018-26340

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Lumbar Spine Surgery with Injection

Experimental group

Description:

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

Treatment:

Drug: Morphine

Drug: Epinephrine

Drug: naropin

Lumbar Spine Surgery without Injection

No Intervention group

Description:

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