Rhomboid Intercostal Block for Video Assisted Thoracic Surgery

NCT04428216 | Completed

• 1 other identifier: Medipol Hospital 13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

Conditions

Lung Diseases

Keywords

Video Assisted Thoracic Surgery; Postoperative pain management; Rhomboid intercostal block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  The primary aim is to compare perioperative and postoperative opioid consumption

  Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours

Secondary Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.

Study Arms (2)

Group RIB = Rhomboid intercostal block group

ACTIVE COMPARATOR

In group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane.

Other: Group RIB

Group C = Control group

NO INTERVENTION

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Interventions

Group RIB OTHER

In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Group RIB = Rhomboid intercostal block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for VATS under general anesthesia

You may not qualify if:

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• pregnancy or lactation,
• patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• 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: 27291611 BACKGROUND

• Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The usage of single-shot ultrasound guided rhomboid intercostal block for analgesia after thoracotomy: Clinical experience in two patients. J Clin Anesth. 2019 Sep;56:98-99. doi: 10.1016/j.jclinane.2019.01.032. Epub 2019 Jan 29. No abstract available.

  PMID: 30708149 BACKGROUND

• Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.

  PMID: 30851503 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 7, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)