NCT04751110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

February 5, 2021

Last Update Submit

November 7, 2021

Conditions

Keywords

rhomboid intercostal blockultrasound guided block

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block

Study Arms (1)

block group

OTHER

ultrasound guided rhomboid intercostal block will performed

Other: ultrasound guided rhomboid intercostal block

Interventions

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.

block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complaint of myofascial pain
  • Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)

You may not qualify if:

  • pregnancy
  • the presence of coagulopathy, or the use of anticoagulants
  • a history of surgery on the block area
  • allergic to bupivacaine
  • decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 24787338BACKGROUND
  • 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.

    PMID: 32392670BACKGROUND
  • 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.

    PMID: 31334619BACKGROUND
  • 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.

    PMID: 27291611BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Selin Guven Kose

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 11, 2021

Study Start

February 10, 2021

Primary Completion

March 15, 2021

Study Completion

April 26, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations