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

Cervicobrachial Neuralgia Clinical Trial

Official title:

Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475445
• Other study ID #: CE/20-04-08
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: July 2021

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Panayota Kapessidou, MD,PhD
• Phone: +32.2.535
• Email: pkapessi[@]ulb.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervicobrachial Neuralgia
• Neuralgia

Intervention

Other:
• Ultrasound-guided transforaminal epidural steroid injection
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.
• Interlaminar epidural steroid injection
Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Score change at 1 month post infiltration when compared to baseline	Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration.; Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)	up to 1 month
Secondary	Patient satisfaction during procedure	Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)	at the end of infiltration
Secondary	Neck disability index (NDI) score (questionnaire)	Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration; The NDI is a standard instrument for measuring self-rated disability due to neck pain.; Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability.	up to 1 month
Secondary	Rate of Procedure failure	The procedure will be considered as a failure if the infiltration is not performed.	up to 30 minutes
Secondary	Incidence of Adverse effects (lipothymia, nausea, vomiting)		up to 1 month
Secondary	Incidence of complications (stroke, hematoma, paralysis)		up to 1 month