- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05073900
Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome
November 25, 2021 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital
Comparison of the Efficacy of Ultrasound Guided Rhomboid Intercostal Block and Erector Spinal Plane Block on Lower Cervical and Interscapular Myofascial Pain Syndrome
The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain
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%.
In this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Ankara, Turkey, 06110
- Diskapi Yildirim Beyazit Training and Research Hospital
-
-
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
Yes
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
- 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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rhomboid intercostal block
Ultrasound guided rhomboid intercostal block
|
two regional anesthesia block techniques are applied
Other Names:
|
|
Active Comparator: Erector spinae plane block
Ultrasound guided erector spinae plane block
|
two regional anesthesia block techniques are applied
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Rating Scale (NRS)
Time Frame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
|
Pain Score Change 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.
|
Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: selin guven kose, Diskapi Teaching and Research Hospital
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)
July 10, 2021
Primary Completion (Actual)
September 10, 2021
Study Completion (Actual)
October 24, 2021
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (Actual)
October 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2021
Last Update Submitted That Met QC Criteria
November 25, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107/29
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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Georgios KotsovolisNot yet recruitingPostoperative Pain | Thoracic Surgery | Ultrasound Guided | Rhomboid Intercostal Block | Thoracic Surgery, Video Assisted | Paravertebral Thoracic Block
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Kocaeli UniversityCompletedPostoperative Pain | AnalgesiaTurkey (Türkiye)