Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05972083
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-07-25
Brief Title:
Serratus Posterior Superior Interfascial Plane Block for Breast Surgery
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Pain Control in Female Patients Underwent Mastectomy and Axillary Lymph Node Dissection A Randomized Prospective Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Regional techniques can be used for postoperative pain control following breast surgery Ultrasound US guided serratus posterior superior block SPSPB is a new interfacial plane block defined by Tulgar et al in 2023 It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib This block provides analgesia in conditions such as interscapular pain chronic myofascial pain syndromes scapulocostal syndrome and shoulder pain The SPS muscle is located at the C7-T2 level It attaches to the lateral edges of the second and fifth ribs It is innervated by the lower cervical and upper intercostal nerves With the SPS block these nerves are blocked and analgesia is provided
Detailed Description:
Mastectomy and axillary lymph node dissection are among the most frequently performed surgeries today and pain control is an important problem affecting patient comfort in the postoperative period in these patients Postoperative pain is an acute pain associated with the inflammatory process that occurs due to surgical trauma and gradually decreases with tissue healing Several analgesic drugs such as opioids are used to prevent this pain but these agents have many unwanted side effects Successful postoperative analgesia occurs in the patient due to pain it is a known fact that it prevents many of the effects such as not being able to breathe easily and delayed mobilization
Regional techniques can be used for postoperative pain control following breast surgery Ultrasound US guided serratus posterior superior block SPSIPB is a new interfacial plane block defined by Tulgar et al in 2023 It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib This block provides analgesia in conditions such as interscapular pain chronic myofascial pain syndromes scapulocostal syndrome and shoulder pain The SPS muscle is located at the C7-T2 level It attaches to the lateral edges of the second and fifth ribs It is innervated by the lower cervical and upper intercostal nerves With the SPS block these nerves are blocked and analgesia is provided
In the cadaveric study of Tulgar et al it was determined that the spread of serratus posterior superior interfacial plane block 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle Spread dye was observed at intercostal levels absent on the right There was prominent staining on both sides of the deep trapezius muscle Both the surface and skin of the rhomboid major were clearly stained while the rhomboid minor was only stained in the skin SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain breast surgery thoracic surgery and shoulder surgery
In this study our aim is to investigate the efficacy of US-guided SPSIPB for postoperative analgesia management after mastectomy and axillary lymph node dissection surgery Our primary aim is to compare postoperative pain scores NRS and our secondary aim is to evaluate the need for rescue analgesics block-related complications dermatome level and side effects allergic reaction nausea vomiting associated with opioid use
Regional techniques can be used for postoperative pain control following breast surgery Ultrasound US guided serratus posterior superior block SPSIPB is a new interfacial plane block defined by Tulgar et al in 2023 It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib This block provides analgesia in conditions such as interscapular pain chronic myofascial pain syndromes scapulocostal syndrome and shoulder pain The SPS muscle is located at the C7-T2 level It attaches to the lateral edges of the second and fifth ribs It is innervated by the lower cervical and upper intercostal nerves With the SPS block these nerves are blocked and analgesia is provided
In the cadaveric study of Tulgar et al it was determined that the spread of serratus posterior superior interfacial plane block 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle Spread dye was observed at intercostal levels absent on the right There was prominent staining on both sides of the deep trapezius muscle Both the surface and skin of the rhomboid major were clearly stained while the rhomboid minor was only stained in the skin SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain breast surgery thoracic surgery and shoulder surgery
In this study our aim is to investigate the efficacy of US-guided SPSIPB for postoperative analgesia management after mastectomy and axillary lymph node dissection surgery Our primary aim is to compare postoperative pain scores NRS and our secondary aim is to evaluate the need for rescue analgesics block-related complications dermatome level and side effects allergic reaction nausea vomiting associated with opioid use
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