Rhomboid Intercostal Block for Video Assisted Thoracic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Lung Diseases

Intervention / Treatment
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* Other: Group RIB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group RIB = Rhomboid intercostal block group<br>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<br>* 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.<br>|
| No Intervention: Group C = Control group<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video Assisted Thoracic Surgery, Postoperative pain management, Rhomboid intercostal block