Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.

NCT04475445 | Unknown

• 1 other identifier: CE/20-04-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicobrachial Neuralgia

Keywords

Neuropathic Cervicobrachial; Ultrasound-guided transforaminal infiltration; Cervical Interlaminar epidural infiltration; Cervical Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score change at 30 minutes post infiltration when compared to baseline

  Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration. Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)

  up to 30 minutes

Secondary Outcomes (6)

• Visual Analogue Score change at 1 month post infiltration when compared to baseline

  up to 1 month

• Patient satisfaction during procedure

  at the end of infiltration

• Neck disability index (NDI) score (questionnaire)

  up to 1 month

• Rate of Procedure failure

  up to 30 minutes

• Incidence of Adverse effects (lipothymia, nausea, vomiting)

  up to 1 month

Study Arms (2)

Ultrasound guided transforaminal epidural steroid injection

EXPERIMENTAL

Other: Ultrasound-guided transforaminal epidural steroid injection

Interlaminar epidural steroid injection

EXPERIMENTAL

Other: Interlaminar epidural steroid injection

Interventions

Ultrasound-guided transforaminal epidural steroid injection OTHER

Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.

Ultrasound guided transforaminal epidural steroid injection

Interlaminar epidural steroid injection OTHER

Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.

Interlaminar epidural steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 26606031 BACKGROUND

• 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.

  PMID: 31365368 BACKGROUND

• 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.

  PMID: 31535205 BACKGROUND

• 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.

  PMID: 19574867 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuritis

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis

Study Officials

• Panayota Kapessidou, MD,PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• Mohamed Ali Bali, MD

  mohamed_bali@stpierre-bru.be

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayota Kapessidou, MD,PhD

CONTACT

+32.2.535; pkapessi@ulb.ac.be

Mohamed Ali Bali, MD

CONTACT

+ 32.2.535; mohamed_bali@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 17, 2020
• Study Start: July 30, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)