Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy

NCT05261581 | Withdrawn Early Phase 1

• 1 other identifier: 13.01.2022-E.46715-23/1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A new regional anaesthetic block technique is described in this issue of Anaesthesia by Chin et al. whereby local anaesthetic is injected within a plane beneath the erector spinae muscle to achieve analgesia for abdominal surgery. After this the block has been used successfully for many implications such as post-herpetic neuralgia, thoracic and abdominal chronic or acute pain management, rib fractures, breast surgery, chronic cancer pain and etc. Cadaveric and radiologic data showed that contrast injected into the tissue plane deep to erector spinae muscle and superficial to the transverse processes and intertransverse connective tissues penetrates anteriorly to anesthetize the spinal nerves. And some cadeveric studies resulted with where both the dorsal and ventral rami of the thoracic spinal nerves were marked with dye after ESPB. Some studies even showed that dye reached to the epidural space. In this manner we we hypothesize that ESPB could be effective with radiculopathy pain.

Conditions

Radiculopathy; Radiculopathy Lumbar; Pain, Back

Outcome Measures

Primary Outcomes (4)

• Pain Assesment

  The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).Numerical Rating Scales have shown high correlations with other pain-assessment tools in several studies. The feasibility of its use and good compliance have also been proven.

  Change from Baseline NPRS at 1st and 3rd months

• The Health Assessment Questionnaire (HAQ)

  The HAQ was developed as a comprehensive measure of outcome in patients with a wide variety of rheumatic diseases. It has also been applied to patients with man diseases and in studies of normal aging. It should be considered a generic rather than a disease-specific instrument. Its focus is on self-reported patient-oriented outcome measures, rather than process measures. The Aides and Devices are assigned to the specific 8 HAQ sections as follows: Dressing: Devices used for dressing (button hook, zipper pull, shoe horn, etc.) Arising: Special or built up chair Eating: Built up or special utensils Walking: Cane, Walker, Crutches, Wheelchair Hygiene: Bathtub bar, Long-handled appliances in bathroom, Raised toilet seat Reach: Long-handled appliances for reach Grip: Jar opener for jars previously opened Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section.

  Change from Baseline HAQ at 1st and 3rd months

• Oswestry Low Back Pain Disability Questionnaire

  The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life and the patient checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

  Change from Baseline ODI at 1st and 3rd months

• Roland-Morris Disability Questionnaire

  RMQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. A patient taking the survey agrees or disagrees with these statements (Yes/No). The final score, out of 24 represents the degree of disability due to low back pain. A maximum score of 24 indicates the greatest degree of disability from back pain. This score may be used to monitor the pain and symptoms of patients with back pain over time.

  Change from Baseline RMQ at 1st and 3rd months

Secondary Outcomes (1)

• Change in Lomber Range of Motion(ROM)

  Change from Baseline Lomber ROM at 1st and 3rd months

Study Arms (2)

Intervention

EXPERIMENTAL

Patients that will get ESPB, NSAID and exercise programme

Procedure: Erector Spinae Plane Block; Drug: NSAID; Behavioral: Home Exercise Programme

Control

ACTIVE COMPARATOR

Patients that will only get NSAID and exercise programme

Drug: NSAID; Behavioral: Home Exercise Programme

Interventions

Erector Spinae Plane Block PROCEDURE

Erector spinae block (ESB) is an ultrasound-guided interfascial plane block. The local anesthetic is injected using ultrasound guidance superficial to transverse process and deep to erector spinae muscle group

Intervention

NSAID DRUG

Non-steroidal anti-inflammatory drugs (NSAIDs) are medicines that are widely used to relieve pain, reduce inflammation.

Also known as: Anti-inflammatory/Analgesic Treatment

Control; Intervention

Home Exercise Programme BEHAVIORAL

Home exercise programme will include some stretches that aid in pain relief by helping take stress off the low back and hips, core stabilization exercises and postural exercises.

Also known as: Exercise

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75
• MRI proven radiculopathy
• Pain level on NRS should be at least 4 and above

You may not qualify if:

• Congenital or acquired musculospinal deformities
• Pregnancy or lactation
• Systemic inflammatory or infectious diseases
• Patients with high risk of bleeding(usage of coumadin etc)
• Malignancy
• Neuromuscular diseases
• Unstable psychiatric condition
• Patient get any kind of intervention(transforaminal or epidural injections, radiofrequency treatment etc) to the pain source

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.

  PMID: 29134518 BACKGROUND

• Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.

  PMID: 32915300 BACKGROUND

• Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

  PMID: 29746445 BACKGROUND

• Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.

  PMID: 30868029 BACKGROUND

• Tulgar S, Thomas DT, Suslu H. Ultrasound guided erector spinae plane block relieves lower cervical and interscapular myofascial pain, a new indication. J Clin Anesth. 2019 Mar;53:74. doi: 10.1016/j.jclinane.2018.10.008. Epub 2018 Oct 19. No abstract available.

  PMID: 30343227 BACKGROUND

• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

  PMID: 30621377 BACKGROUND

• Takahashi H, Suzuki T. Erector spinae plane block for low back pain in failed back surgery syndrome: a case report. JA Clin Rep. 2018 Aug 27;4(1):60. doi: 10.1186/s40981-018-0198-6.

  PMID: 32026979 BACKGROUND

• Tulgar S, Balaban O. Spread of local anesthetic in erector spine plane block at thoracic and lumbar levels. Reg Anesth Pain Med. 2019 Jan;44(1):134-135. doi: 10.1136/rapm-2018-000027. No abstract available.

  PMID: 30640667 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Back Pain

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Antirheumatic Agents; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 2, 2022
• Study Start: March 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)