Clinical trial NCT04475445: Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
Official title: Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervicobrachial Neuralgia
Keywords: Neuropathic Cervicobrachial
Ultrasound-guided transforaminal infiltration
Cervical Interlaminar epidural infiltration
Cervical Chronic Pain
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA) I-III
* Chronic unilateral cervicobrachial pain
* Allowed Steroid infiltration

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy or intolerance to any of the drugs/materials used in this study,
* Participation in another interventional study
* Systemic anticoagulation,
* Infection at the puncture site
* Patient refusal.

Primary outcomes:
measure: Visual Analogue Score change at 30 minutes post infiltration when compared to baseline
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Visual Analogue Score change at 1 month post infiltration when compared to baseline
timeFrame: up to 1 month
measure: Patient satisfaction during procedure
timeFrame: at the end of infiltration
measure: Neck disability index (NDI) score (questionnaire)
timeFrame: up to 1 month
measure: Rate of Procedure failure
timeFrame: up to 30 minutes
measure: Incidence of Adverse effects (lipothymia, nausea, vomiting)
timeFrame: up to 1 month
measure: Incidence of complications (stroke, hematoma, paralysis)
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota Kapessidou, MD,PhD
role: STUDY_DIRECTOR
affiliation: mohamed_bali@stpierre-bru.be
name: Mohamed Ali Bali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaye AD, Manchikanti L, Abdi S, Atluri S, Bakshi S, Benyamin R, Boswell MV, Buenaventura R, Candido KD, Cordner HJ, Datta S, Doulatram G, Gharibo CG, Grami V, Gupta S, Jha S, Kaplan ED, Malla Y, Mann DP, Nampiaparampil DE, Racz G, Raj P, Rana MV, Sharma ML, Singh V, Soin A, Staats PS, Vallejo R, Wargo BW, Hirsch JA. Efficacy of Epidural Injections in Managing Chronic Spinal Pain: A Best Evidence Synthesis. Pain Physician. 2015 Nov;18(6):E939-1004.
citation: Banik RK, Chen Chen CC. Spinal Epidural Hematoma after Interlaminar Cervical Epidural Steroid Injection. Anesthesiology. 2019 Dec;131(6):1342-1343. doi: 10.1097/ALN.0000000000002896. No abstract available.
citation: Bush K, Mandegaran R, Robinson E, Zavareh A. The safety and efficiency of performing cervical transforaminal epidural steroid injections under fluoroscopic control on an ambulatory/outpatient basis. Eur Spine J. 2020 May;29(5):994-1000. doi: 10.1007/s00586-019-06147-2. Epub 2019 Sep 18.
citation: Narouze SN, Vydyanathan A, Kapural L, Sessler DI, Mekhail N. Ultrasound-guided cervical selective nerve root block: a fluoroscopy-controlled feasibility study. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):343-8. doi: 10.1097/AAP.0b013e3181ac7e5c.