Peri-Incisional Drug Injection in Lumbar Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lumbar Disc Herniation Degenerative Disc Disease Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This is a single blind study in which participants are unaware of whether or not they received a peri-incisional injection of pain medication during their surgery.

Study Groups

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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.

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Epinephrine

Intervention Type DRUG

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

naropin

Intervention Type DRUG

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Lumbar Spine Surgery without Injection

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Morphine

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Intervention Type DRUG

Epinephrine

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Intervention Type DRUG

naropin

Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No