Lumbar Disc HerniationPhase 3NCT03513445
Peri-Incisional Drug Injection in Lumbar Spine Surgery
A Phase 3 study testing Morphine, Epinephrine and naropin in people with Lumbar Disc Herniation and Degenerative Disc Disease, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Degenerative Disc Disease, Spondylolisthesis
- What is being tested?
- Morphine, Epinephrine and naropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery
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.
- Being tested
- Morphine, Epinephrine, naropin
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
EpinephrineDrug
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
naropinDrug
Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Spine Surgery with Injection | Experimental | Patients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery. Receives: Drug: Morphine; Drug: Epinephrine; Drug: naropin |
| Lumbar Spine Surgery without Injection | No intervention | Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative narcotic use
Measured: Up to 6 weeks
Secondary outcomes (2)
Patients' self-reported pain (CAPA) scores
Evaluates
- intensity of pain
- effect of pain on functionality
- effect of pain on sleep
- efficacy of therapy
- progress toward comfort
Measured: Up to 6 weeks
Length of hospital stay
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513445
- Sponsor's protocol ID
- ORSU-2018-26340
- Status last verified
- Aug 2022
- First submitted
- 12 Apr 2018
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peri-Incisional Multimodal Drug Injection in Reducing Post-Operative Pain Following Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT03513445
- Acronym / sponsor ID
- ORSU-2018-26340
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Spine Surgery with Injection | Experimental | Drug: Morphine, Drug: Epinephrine, Drug: naropinPatients undergoing lumbar spine surgery will receive a peri-incisional injection of pain medications (morphine, epinephrine, and ropivacaine) during their surgery. |
| Lumbar Spine Surgery without Injection | No intervention | –Patients undergoing lumbar spine surgery will NOT receive a peri-incisional injection of pain medications during their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineMorphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery. | Drug | Lumbar Spine Surgery with Injection |
| EpinephrineMorphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery. | Drug | Lumbar Spine Surgery with Injection |
| naropinMorphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery. | Drug | Lumbar Spine Surgery with Injection |
Primary outcome
Post-operative narcotic use
Time frame: Up to 6 weeks
2 secondary outcomes
Patients' self-reported pain (CAPA) scores
Time frame: Up to 6 weeks
Length of hospital stay
Time frame: Up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine, Epinephrine and naropin in people with Lumbar Disc Herniation and Degenerative Disc Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative narcotic use (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.