Erector Spinae Plane Block vs Transforaminal Epidural Injection

Discogenic Low Back Pain Clinical Trial

Official title:

Erector Spinae Plane Block Versus Transforaminal Epidural Injection in Chronic Discogenic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212845
• Other study ID #: ESPB vs TF
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2020
• Source: Ataturk University
• Contact: Ahmet Yayik, MD
• Phone: 00905544259287
• Email: m_yayik[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbar disc herniation is the main cause of low back pain and radicular leg pain. Steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. Epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection.

Ultrasound-guided erector spina plan block (ESPB) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. The distribution of local anesthesia in the ESPB from the paravertebral area to the transforaminal and epidural space has been shown in studies.

The aim of this study was to compare the efficacy of ultrasound-guided ESPB and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist's physiologic state I-III patients

• Patients with unilateral radicular pain and low back pain persisting despite medical treatment.

Exclusion Criteria:

• Spinal cord disease or spinal mechanical instability,

• Previous low back surgery,

• More than two levels of lumbar disc hernia,

• Allergic to local anesthetic drugs to be used,

• Use of oral anticoagulants,

• Uncontrolled diabetes mellitus type I and II

Related Conditions & MeSH terms

• Back Pain
• Discogenic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Bupivacaine;Dexamethasone Solution for Injection
8 mg Dexamethasone and %0.25 bupivacaine

Device:
• Fluoroscopy
Fluoroscopy-guided transforaminal injection
• Ultrasound
Ultrasound-guided erector spinae plane block

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Celik M, Tulgar S, Ahiskalioglu A, Alper F. Is high volume lumbar erector spinae plane block an alternative to transforaminal epidural injection? Evaluation with MRI. Reg Anesth Pain Med. 2019 Apr 16. pii: rapm-2019-100514. doi: 10.1136/rapm-2019-100514. [Epub ahead of print] — View Citation

Makkar JK, Gourav KKP, Jain K, Singh PM, Dhatt SS, Sachdeva N, Bhadada S. Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized Double-Blind Trial. Pain Physician. 2019 Nov;22(6):561-573. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain score	Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)	Post injection sixth month
Secondary	Oswestry Disability Index	0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.	Post injection first, third and sixth month