Radiculopathy Clinical Trial
Official title:
Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | November 30, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Aged between 18 and 75 - MRI proven radiculopathy - Pain level on NRS should be at least 4 and above Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in Lomber Range of Motion(ROM) | The Lumbar Spine normal active range of motion is as follows:
Flexion: 70-90* Extension: 30* Lateral Flexion: 30* Rotation: 30* Decreased in Range of motion in lumbar spine mostly caused by muscle/fascia adhesion and tightness limiting your mobility. Another more likely scenario is that fixation in vertebra or another cause of pain. The motion restriction and muscle tightness often exist together but can be separate as well. |
Change from Baseline Lomber ROM at 1st and 3rd months |
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