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Use of Local Intraoperative Steroid in MIS TLIF

NCT ID: NCT03308084

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-13

Study Completion Date

2019-05-03

Brief Summary

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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

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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

Conditions

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Dysphasia

Keywords

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transforaminal lumbar interbody fusion, methylprednisolone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Local Depomedrol plus IV dexamethasone

Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure

Dexamethasone

Intervention Type DRUG

Administration of 10mg Dexamethasone IV intraoperatively

IV dexamethasone

Standard systemic (IV) dexamethasone only

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

Administration of 10mg Dexamethasone IV intraoperatively

Interventions

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Methylprednisolone

Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure

Intervention Type DRUG

Dexamethasone

Administration of 10mg Dexamethasone IV intraoperatively

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kern Singh

Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kern Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 19023571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21417699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21121754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24885519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12177541 (View on PubMed)

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. Print 2019 Feb 1.

Reference Type DERIVED
PMID: 30497132 (View on PubMed)

Other Identifiers

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15052003

Identifier Type: -

Identifier Source: org_study_id