Use of Local Intraoperative Steroid in MIS TLIF
Primary Purpose
Dysphasia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Dysphasia focused on measuring transforaminal lumbar interbody fusion, methylprednisolone
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
Allergies or other contraindications to medicines in the protocol including:
(a) Existing history of gastrointestinal bleeding
- Current Smokers
- Lumbar spine trauma
- Bilateral cages
- Lack of consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Local Depomedrol plus IV dexamethasone
IV dexamethasone
Arm Description
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Standard systemic (IV) dexamethasone only
Outcomes
Primary Outcome Measures
Postoperative Pain
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Secondary Outcome Measures
Physical Functioning
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
Disability
Oswestry Disability Index score as compared to preoperative score
General health status
Short Form-12 Survey scores as compared to preoperative value
Narcotic Consumption
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
Intra-operative adverse events
Blood loss, length of surgery, procedural details, complications
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
Full Information
NCT ID
NCT03308084
First Posted
October 5, 2017
Last Updated
November 18, 2020
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03308084
Brief Title
Use of Local Intraoperative Steroid in MIS TLIF
Official Title
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2015 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 (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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphasia
Keywords
transforaminal lumbar interbody fusion, methylprednisolone
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local Depomedrol plus IV dexamethasone
Arm Type
Active Comparator
Arm Description
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Arm Title
IV dexamethasone
Arm Type
Placebo Comparator
Arm Description
Standard systemic (IV) dexamethasone only
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Administration of 10mg Dexamethasone IV intraoperatively
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Physical Functioning
Description
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
Time Frame
2 years postoperative
Title
Disability
Description
Oswestry Disability Index score as compared to preoperative score
Time Frame
2 years postoperative
Title
General health status
Description
Short Form-12 Survey scores as compared to preoperative value
Time Frame
2 years postoperative
Title
Narcotic Consumption
Description
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Time Frame
1 week postoperative
Title
Length of Stay
Description
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
Time Frame
1 week postoperative
Title
Intra-operative adverse events
Description
Blood loss, length of surgery, procedural details, complications
Time Frame
day of surgery
Title
Post-operative adverse events
Description
Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Time Frame
1 week postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Allergies or other contraindications to medicines in the protocol including:
(a) Existing history of gastrointestinal bleeding
Current Smokers
Lumbar spine trauma
Bilateral cages
Lack of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kern Singh, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19023571
Citation
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.
Results Reference
background
PubMed Identifier
21417699
Citation
McGirt 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.
Results Reference
background
PubMed Identifier
21121754
Citation
Ranguis 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.
Results Reference
background
PubMed Identifier
24885519
Citation
Jamjoom 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.
Results Reference
background
PubMed Identifier
12177541
Citation
Debi 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.
Results Reference
background
PubMed Identifier
30497132
Citation
Haws 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.
Results Reference
derived
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Use of Local Intraoperative Steroid in MIS TLIF
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