Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625879
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
The Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of the Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy as a Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
SAPB MTPB
Brief Summary:
Several studies proved that the serratus anterior plane blockSAPB offer analgesia not inferior or as effective to opioids which is mainstay of analgesia chai et al 2023
In this study we will compare the analgesic effect of the serratus anterior plane block versus a new paraspinal technique block which is the midpoint transverse process to pleura MTP block for postoperative analgesia after modefied radical mastectomy
In this study we will compare the analgesic effect of the serratus anterior plane block versus a new paraspinal technique block which is the midpoint transverse process to pleura MTP block for postoperative analgesia after modefied radical mastectomy
Detailed Description:
Breast cancer is the most common cancer in women both in the developed and less developed world In 2012 it represented about 12 percent of all new cancer cases and 25 percent of all cancers in women Jain et al 2020
Surgery is one of the mainstays of treatment and a procedure called modified radical mastectomy MRM is now a standard surgical treatment for early stage breast cancersThese procedures cause significant acute pain and may progress to chronic pain states in 25-60 of cases Andersen and Kehlet 2011
Though various risk factors have been suggested inappropriate acute postoperative pain management has been associated with the development of chronic post mastectomy pain a complex post-surgical pain syndrome that may occur following any type of breast surgery Macrea 2001 The traditional opioid based analgesia remains the mainstay however Different techniques including regional local anaesthetic infiltration paravertebral and neuroaxial analgesia anti_neuropathic analgesics and NMDA antagonists have all been used either singly or in combination Macrea 2001 Post operative pain is usually acute nociceptive pain it occurs as normal response to noxious insult or injury Dworkin et al 2007
Inadequately controlled pain negatively affects quality of life functional recovery and increase the risk for post-surgical complications Apfelbaum 2003
After the application of ultrasound in anaesthetic practiceseveral blocks have been described recentlySerratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs Chin et al 2021 in which the intercostobrachialis nerve lateral cutaneous branches of the intercostal nerves T2-T9long thoracic nerveand the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles Blanco et al 2013
The MTP block described by Costache et al 2017 is a new block described for thoracic surgery it involves deposition of the local anesthetic drug midway between the transverse process and the pleura Postulated that the local anesthetic deposited at this point will reach the paravertebral space through several possible mechanisms such as medially through the gap between the superior costotransverse ligament SCTL and vertebral bodies through fenestrations in SCTL and laterally through the internal intercostal membrane the neural target will be the dorsal and ventral rami of spinal nerves spanning 1-3 levels cranial and caudal to the level of injectionthe advantage of the MTP block over the conventional thoracic paravertebral block is that the visualization of SCTL is not required which might be difficult in patients with obesity The second advantage is that the target point of the needle is very superficial and far from structures such as the pleura and neurovascular bundles making this novel block much safer Syal et al 2020
2AIM OBJECTIVES
The aim of work is to evaluate The Effectiveness of Ultrasound Guided mid-point transverse process to pleura block versus the serratus anterior plane block for postoperative analgesia after modefied radical mastectomy
Surgery is one of the mainstays of treatment and a procedure called modified radical mastectomy MRM is now a standard surgical treatment for early stage breast cancersThese procedures cause significant acute pain and may progress to chronic pain states in 25-60 of cases Andersen and Kehlet 2011
Though various risk factors have been suggested inappropriate acute postoperative pain management has been associated with the development of chronic post mastectomy pain a complex post-surgical pain syndrome that may occur following any type of breast surgery Macrea 2001 The traditional opioid based analgesia remains the mainstay however Different techniques including regional local anaesthetic infiltration paravertebral and neuroaxial analgesia anti_neuropathic analgesics and NMDA antagonists have all been used either singly or in combination Macrea 2001 Post operative pain is usually acute nociceptive pain it occurs as normal response to noxious insult or injury Dworkin et al 2007
Inadequately controlled pain negatively affects quality of life functional recovery and increase the risk for post-surgical complications Apfelbaum 2003
After the application of ultrasound in anaesthetic practiceseveral blocks have been described recentlySerratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs Chin et al 2021 in which the intercostobrachialis nerve lateral cutaneous branches of the intercostal nerves T2-T9long thoracic nerveand the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles Blanco et al 2013
The MTP block described by Costache et al 2017 is a new block described for thoracic surgery it involves deposition of the local anesthetic drug midway between the transverse process and the pleura Postulated that the local anesthetic deposited at this point will reach the paravertebral space through several possible mechanisms such as medially through the gap between the superior costotransverse ligament SCTL and vertebral bodies through fenestrations in SCTL and laterally through the internal intercostal membrane the neural target will be the dorsal and ventral rami of spinal nerves spanning 1-3 levels cranial and caudal to the level of injectionthe advantage of the MTP block over the conventional thoracic paravertebral block is that the visualization of SCTL is not required which might be difficult in patients with obesity The second advantage is that the target point of the needle is very superficial and far from structures such as the pleura and neurovascular bundles making this novel block much safer Syal et al 2020
2AIM OBJECTIVES
The aim of work is to evaluate The Effectiveness of Ultrasound Guided mid-point transverse process to pleura block versus the serratus anterior plane block for postoperative analgesia after modefied radical mastectomy
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