DysphasiaPhase 3NCT03308084
Use of Local Intraoperative Steroid in MIS TLIF
A Phase 3 study testing Methylprednisolone and Dexamethasone in people with Dysphasia, run by Rush University Medical Center.
Trial summary
The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dysphasia
- What is being tested?
- Methylprednisolone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2015to 3 May 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a primary 1- to 2-level MIS TLIF
- Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- Patients able to provide informed consent
Who cannot join
- Allergies or other contraindications to medicines in the protocol including:
- Existing history of gastrointestinal bleeding
- Current Smokers
- Lumbar spine trauma
- Bilateral cages
- Lack of consent
About this study
Official title: Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).
Read the detailed description
Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients.
The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF.
The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have:
- Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.
- Shorter hospital stay compared to participants receiving only systemic dexamethasone.
- Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone
- Conditions
- Dysphasia
- Being tested
- Methylprednisolone, Dexamethasone
- Keywords
- transforaminal lumbar interbody fusion, methylprednisolone
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
DexamethasoneDrug
Administration of 10mg Dexamethasone IV intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Local Depomedrol plus IV dexamethasone | Active comparator | Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone Receives: Drug: Methylprednisolone; Drug: Dexamethasone |
| IV dexamethasone | Placebo comparator | Standard systemic (IV) dexamethasone only Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Measured: 2 years postoperative
Secondary outcomes (7)
Physical Functioning
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
Measured: 2 years postoperative
Disability
Oswestry Disability Index score as compared to preoperative score
Measured: 2 years postoperative
General health status
Short Form-12 Survey scores as compared to preoperative value
Measured: 2 years postoperative
Narcotic Consumption
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Measured: 1 week postoperative
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
Measured: 1 week postoperative
Intra-operative adverse events
Blood loss, length of surgery, procedural details, complications
Measured: day of surgery
Post-operative adverse events
Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start13 Nov 2015
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DysphasiaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kern Singh, Rush University Medical Center
- Investigators
- Kern Singh, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308084
- Sponsor's protocol ID
- 15052003
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2017
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.
PubMed 19023571McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
PubMed 21417699Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.
PubMed 21121754Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.
PubMed 24885519Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.
PubMed 12177541Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584. Print 2019 Feb 1.
PubMed 30497132
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03308084
- Acronym / sponsor ID
- 15052003
- Conditions
- Dysphasia
- Keywords
- transforaminal lumbar interbody fusion, methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 12 Oct 2017 (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.
The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).
Detailed description
Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients.
The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF.
The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have:
- Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.
- Shorter hospital stay compared to participants receiving only systemic dexamethasone.
- Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Depomedrol plus IV dexamethasone | Active comparator | Drug: Methylprednisolone, Drug: DexamethasoneLocal intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone |
| IV dexamethasone | Placebo comparator | Drug: DexamethasoneStandard systemic (IV) dexamethasone only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a primary 1- to 2-level MIS TLIF
- Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- Patients able to provide informed consent
Key exclusion criteria (6 listed)
- Allergies or other contraindications to medicines in the protocol including:
- Current Smokers
- Lumbar spine trauma
- Bilateral cages
- Lack of consent
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 |
|---|---|---|
| MethylprednisoloneApplication of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure | Drug | Local Depomedrol plus IV dexamethasone |
| DexamethasoneAdministration of 10mg Dexamethasone IV intraoperatively | Drug | IV dexamethasone, Local Depomedrol plus IV dexamethasone |
Primary outcome
Postoperative Pain
Time frame: 2 years postoperative
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
7 secondary outcomes
Physical Functioning
Time frame: 2 years postoperative
Disability
Time frame: 2 years postoperative
General health status
Time frame: 2 years postoperative
Narcotic Consumption
Time frame: 1 week postoperative
Length of Stay
Time frame: 1 week postoperative
Intra-operative adverse events
Time frame: day of surgery
Post-operative adverse events
Time frame: 1 week postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 19023571Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.
- Background: PubMed 21417699McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
- Background: PubMed 21121754Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.
- Background: PubMed 24885519Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.
- Background: PubMed 12177541Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.
- Derived from this study: PubMed 30497132Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584. Print 2019 Feb 1.
- 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.
Kern Singh, MD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone and Dexamethasone in people with Dysphasia, run by Rush University Medical Center.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain (time frame: 2 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308084, which also lists 6 linked publications.
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 20 Nov 2020.