Use of Local Intraoperative Steroid in MIS TLIF

Dysphasia Clinical Trial

Official title:

Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308084
• Other study ID #: 15052003
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2015
• Est. completion date: May 3, 2019

Study information

• Verified date: November 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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).

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:

1. Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.

2. Shorter hospital stay compared to participants receiving only systemic dexamethasone.

3. Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Dysphasia

Intervention

Drug:
• Methylprednisolone
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
• Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

References & Publications (5)

Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed	2 years postoperative
Secondary	Physical Functioning	Patient-Reported Outcomes Measurement Information System score as compared to preoperative value	2 years postoperative
Secondary	Disability	Oswestry Disability Index score as compared to preoperative score	2 years postoperative
Secondary	General health status	Short Form-12 Survey scores as compared to preoperative value	2 years postoperative
Secondary	Narcotic Consumption	The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents	1 week postoperative
Secondary	Length of Stay	The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.	1 week postoperative
Secondary	Intra-operative adverse events	Blood loss, length of surgery, procedural details, complications	day of surgery
Secondary	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	1 week postoperative