Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:23 AM
Study NCT ID:
NCT07394868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block
Sponsor:
Ankara Etlik City Hospital
Organization:
Study Overview
Official Title:
Comparison of the Analgesic Efficacy of Combined Superficial and Deep Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block Following Modified Radical Mastectomy Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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:
Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks.
Detailed Description:
Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks. Superficial serratus anterior plane block procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the serratus anterior muscle, under the latissimus dorsi muscle, and hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. KSAB procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the 4th rib, under the serratus anterior muscle, and onto the rib. Hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. The needle is then withdrawn 1-2 cm and positioned over the serratus anterior muscle, below the latissimus dorsi muscle. Hydrodissection with 2 ml of saline is performed to ensure accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. A total of 30 ml of bupivacaine will be injected, and the procedure will be terminated. In our clinic, multimodal analgesia is preferred for patients undergoing mastectomy. Peripheral nerve blocks (for all suitable and consenting patients) are used in conjunction with intravenous analgesic agents. Both block types are routinely applied in suitable patients who have undergone mastectomy.
Study Oversight
Has Oversight DMC:
False
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?: