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Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound guided rhomboid intercostal block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myofascial Pain Syndrome focused on measuring rhomboid intercostal block, ultrasound guided block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diskapi Yildirim Beyazit Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

block group

Arm Description

ultrasound guided rhomboid intercostal block will performed

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) 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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2021
Last Updated
November 7, 2021
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04751110
Brief Title
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome
Official Title
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome: Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
rhomboid intercostal block, ultrasound guided block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
block group
Arm Type
Other
Arm Description
ultrasound guided rhomboid intercostal block will performed
Intervention Type
Other
Intervention Name(s)
ultrasound guided rhomboid intercostal block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) Pain Score Change
Description
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.
Time Frame
Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selin Guven Kose
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24787338
Citation
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.
Results Reference
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PubMed Identifier
32392670
Citation
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. No abstract available.
Results Reference
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PubMed Identifier
31334619
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
27291611
Citation
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.
Results Reference
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Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome

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