Viewing Study NCT06533566



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06533566
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-29

Brief Title: Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Erector Spinae Plane Block Versus Local Wound Infiltration on Postoperative Pain After Modified Radical Mastectomy
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration drain block for patients scheduled for modified radical mastectomy surgery
Detailed Description: Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally Modified Radical Mastectomy MRM is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain Poor postoperative pain management can lead to increased chances of the development of chronic pain Therefore adequate postoperative pain management after breast cancer surgery is essential Regional block for pain management has many advantages in such patients including provision of adequate analgesia reduced need for opioids decreased postoperative nausea vomiting and postoperative pulmonary complications It also facilitates early ambulation Thoracic Epidural TE paravertebral block PVB pectoral nerve I pectoral nerve II blocks serratus anterior plane block and erector spinae plan block have been used with good results In particular the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients Further in meta-analysis the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption In ESP block local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami ventral rami and lateral cutaneous branches of intercostal nerves Also in many situations a superior postoperative analgesia yet avoiding the detrimental effects of opioids can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period

Study Oversight

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