Rhomboid Intercostal Block for Video Assisted Thoracic Surgery

The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block for Pain Management Following Video Assisted Thoracic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Other: Group RIB

Detailed Description

Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. 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. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bagcilar
    • Istanbul, Bagcilar, Turkey, 34070
      • Istanbul Medipol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group C = Control group; 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.
Active Comparator: Group RIB = Rhomboid intercostal block group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores (Visual analogue scores-VAS)	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.

Collaborators and Investigators

• Sponsor: Medipol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative pain management; Video Assisted Thoracic Surgery; Rhomboid intercostal block
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Medipol Hospital 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No