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

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

      • 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

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.

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.
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.

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.

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

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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