Peri-Incisional Drug Injection in Lumbar Spine Surgery

Sponsor

University of Minnesota (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03513445

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation Degenerative Disc Disease Spondylolisthesis	Drug: Morphine Drug: Epinephrine Drug: naropin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Lumbar Spine Surgery without Injection Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: Lumbar Spine Surgery without Injection

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

Outcome Measures

Primary Outcome Measures

Post-operative narcotic use [Up to 6 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT03513445

Other Study ID Numbers:

ORSU-2018-26340

First Posted:

May 1, 2018

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Intervertebral Disc Degeneration

Intervertebral Disc Displacement

Study Results

No Results Posted as of Aug 19, 2022