- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751110
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome
November 7, 2021 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome: Observational Study
Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016.
It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle.
It has been used effectively in patients with chronic pain.
Recently published report has shown that rhomboid intercostal block (RIB) may provide effective pain control for myofascial pain syndrome (MPS), too.
MPS is a regional pain syndrome characterized by trigger points detected in one or more regional muscle groups.
The investigators planned a prospective observational study, a total of 30 patients who will apply to our clinic with MPS, will register in research.
The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%.
Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016.
It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle.
It has been used effectively in patients with chronic pain.
The investigators planned a prospective observational study.From february to march 10 2021, a total of 30 patients who will apply to our clinic with MPS, will register in research.
The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcome Ultrasound guided RIB will applied with linear probe, in plane technique.
Block needle was inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula.
13ml of bupivacaine 0.25% and 8mg dexamethasone mixture will inject into the fascial plane.
Numerical Rating Scale (NRS) will recorded before and after the block at 30 minutes, day 1, 1-2-4-6 weeks.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ankara, Turkey, 06110
- Diskapi Yildirim Beyazit Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Complaint of myofascial pain
- Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)
Exclusion Criteria:
- pregnancy
- the presence of coagulopathy, or the use of anticoagulants
- a history of surgery on the block area
- allergic to bupivacaine
- decline to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: block group
ultrasound guided rhomboid intercostal block will performed
|
A linear ultrasound probe was medially placed in the sagittal plane on the medial border of the scapula at the T5-T7 level.
We inserted a 22-gauge needle into the fascial plane between the rhomboid major and intercostal muscles in a craniocaudal direction and injected 15 ml mixture of 0.25% bupivacaine with 8 mg of dexamethasone into the fascial plane.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS) Pain Score Change
Time Frame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
|
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain."
The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
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Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.
- Ekinci M, Ciftci B, Alici HA, Ahiskalioglu A. Ultrasound-guided rhomboid intercostal block effectively manages myofascial pain. Korean J Anesthesiol. 2020 Dec;73(6):564-565. doi: 10.4097/kja.20211. Epub 2020 May 12.
- Piraccini E, De Lorenzo E, Maitan S. Rhomboid intercostal block for myofascial pain syndrome in a patient with amyotrophic lateral sclerosis. Minerva Anestesiol. 2019 Dec;85(12):1367-1369. doi: 10.23736/S0375-9393.19.13791-1. Epub 2019 Jul 22.
- Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2021
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
April 26, 2021
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (Actual)
February 11, 2021
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 7, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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