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

NCT ID: NCT04475445

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2021-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound guided transforaminal epidural steroid injection

Group Type: EXPERIMENTAL

Ultrasound-guided transforaminal epidural steroid injection

Intervention Type: 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.

Interlaminar epidural steroid injection

Group Type: EXPERIMENTAL

Interlaminar epidural steroid injection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panayota Kapessidou, MD,PhD

Role: STUDY_DIRECTOR

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

Mohamed Ali Bali, MD

Role: PRINCIPAL_INVESTIGATOR

mohamed_bali@stpierre-bru.be

Locations

CHU Saint-Pierre

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Panayota Kapessidou, MD,PhD

Role: CONTACT

pkapessi@ulb.ac.be

+32.2.535 ext. 3750

Mohamed Ali Bali, MD

Role: CONTACT

mohamed_bali@stpierre-bru.be

+ 32.2.535 ext. 3758

Facility Contacts

Mohamed Ali Bali, MD

Role: primary

mohamed_bali@stpierre-bru.be

+32.2.535 ext. 3758

Panayota Kapessidou, MD

Role: backup

pkapessi@ulb.ac.be

+32.2.535 ext. 3750

References

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.

Reference Type: BACKGROUND

PMID: 26606031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31365368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31535205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19574867 (View on PubMed)

Other Identifiers

CE/20-04-08

Identifier Type: -

Identifier Source: org_study_id