Viewing Study NCT05961735



Ignite Creation Date: 2024-05-06 @ 7:19 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05961735
Status: COMPLETED
Last Update Posted: 2024-05-29
First Post: 2023-07-14

Brief Title: Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy
Sponsor: Ankara Etlik City Hospital
Organization: Ankara Etlik City Hospital

Study Overview

Official Title: Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy
Status: COMPLETED
Status Verified Date: 2024-10
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: In this study PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 025 bupivacaine All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period Pain nausea-vomiting additional analgesic and antiemetic drug requirement within 24 hours postoperatively will be compared between groups

In this study it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy
Detailed Description: Breast cancer ranks first among the most common malignant neoplasms in women Surgery has been a mainstay of breast cancer treatment for several decades and historically a modified radical mastectomy was the primary method of treatment for breast cancer Poorly controlled acute postoperative pain is associated with increased morbidity functional and quality-of-life impairment Additionally severe acute postoperative pain is found to be a risk factor for chronic pain

Thoracic paravertebral thoracic epidural intercostal nerve and interscalene brachial plexus blocks have been used for anesthesia and abirritation during modified radical mastectomy but their application is limited due to the complex nature of the procedures and serious complications There is growing interest in the pectoralis nerve PECS blocks and serratus anterior block SAB which are less invasive as an analgesic technique during breast surgeries to reduce postoperative pain

The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point Local anaesthetic is placed between pectorals major and minor as for a Pecs I block and then between pectoralis minor and serratus anterior muscles

Numerous clinical studies focusing on the analgesic potential of PECS block in breast augmentation surgery small breast surgery and breast cancer surgery have yielded positive results SAD is more superficial easy to access and less likely to have complications like PECS block SAPB can be implemented in two ways Deep SAB DSAB is applied under the serratus anterior muscle while superficial SAB YSAB is applied over the serratus anterior muscle In recent years deep and superficial SAB that is combined SAB CSAB has been started to be applied in order to increase the effect area of local anesthetics and to prevent block failure

In this study PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 025 bupivacaine All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period Pain nausea-vomiting additional analgesic and antiemetic drug requirement within 24 hours postoperatively will be compared between groups

In this study it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy

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