Erector Spinae Plane Block vs Transforaminal Epidural Injection

NCT ID: NCT04212845

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Discogenic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group ESP

Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone

Group Type ACTIVE_COMPARATOR

Bupivacaine;Dexamethasone Solution for Injection

Intervention Type DRUG

8 mg Dexamethasone and %0.25 bupivacaine

Ultrasound

Intervention Type DEVICE

Ultrasound-guided erector spinae plane block

Group TF

Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone

Group Type ACTIVE_COMPARATOR

Bupivacaine;Dexamethasone Solution for Injection

Intervention Type DRUG

8 mg Dexamethasone and %0.25 bupivacaine

Fluoroscopy

Intervention Type DEVICE

Fluoroscopy-guided transforaminal injection

Interventions

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Bupivacaine;Dexamethasone Solution for Injection

8 mg Dexamethasone and %0.25 bupivacaine

Intervention Type DRUG

Fluoroscopy

Fluoroscopy-guided transforaminal injection

Intervention Type DEVICE

Ultrasound

Ultrasound-guided erector spinae plane block

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Murat Yayik

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ahmet Yayik, MD

Role: CONTACT

00905544259287

Ali Ahiskalioglu, MD

Role: CONTACT

00905444424831

Facility Contacts

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Ahmet Murat Yayik, MD

Role: primary

00905544259287

References

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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:rapm-2019-100514. doi: 10.1136/rapm-2019-100514. Online ahead of print. No abstract available.

Reference Type BACKGROUND
PMID: 30992410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31775403 (View on PubMed)

Other Identifiers

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ESPB vs TF

Identifier Type: -

Identifier Source: org_study_id

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