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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04751110
Other study ID # 98/05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2021
Est. completion date April 26, 2021

Study information

Verified date November 2021
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 26, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
ultrasound guided rhomboid intercostal block
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.

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View 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. — View Citation

Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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