Viewing Study NCT04752150



Ignite Creation Date: 2024-05-06 @ 3:47 PM
Last Modification Date: 2024-10-26 @ 1:56 PM
Study NCT ID: NCT04752150
Status: COMPLETED
Last Update Posted: 2022-01-21
First Post: 2021-02-01

Brief Title: ESPB and RIB for Pain Management Following Mastectomy Surgery
Sponsor: Medipol University
Organization: Medipol University

Study Overview

Official Title: Comparison of Ultrasound-Guided Erector Spinae Plane Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery Postoperative effective pain treatment provides early mobilization and shorter hospital stay The US-guided erector spina plane block ESPB may be used for postoperative pain treatment following breast surgery It is a novel interfascial block that was defined by Forero 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 It has been reported that RIB may provide effective analgesia management for several breast surgeries

The primary aim of the study is to compare postoperative pain scores VAS and the secondary aim is to evaluate postoperative opioid consumption adverse effects related with opioids allergic reaction nausea vomiting
Detailed Description: Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery Postoperative effective pain treatment provides early mobilization and shorter hospital stay thus complications due to hospitalization such as infection and thromboembolism may be reduced

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery Ultrasound US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice 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 breast surgeries

The US-guided erector spina plane block ESPB is defined by Forero et al ESPB provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level ESPB contains a local anesthetic injection into the deep fascia of erector spinae Visualization of sonoanatomy is easy and the spread of local anesthesic agents can be easily seen under the erector spinae muscle Thus analgesia occurs in several dermatomes with cephalad-caudad way In the literature it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery breast surgery thoracoscopic and abdominal operations

The aim of this study is to evaluate the efficacy of the US-guided ESPB and RIB for postoperative analgesia after mastectomy and axillary dissection surgery The primary aim is to compare postoperative pain scores VAS and the secondary aim is to evaluate opioid consumption adverse effects related with opioids allergic reaction nausea vomiting

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None