Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416891
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-12
Brief Title:
Effect of Adding Dexamethasone to Bupivacaine 025 in SCPB on Surgical Field Visibility During Tympanomastoid Surgery
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Adding Dexamethasone to Bupivacaine 025 in Superficial Cervical Plexus Block on Surgical Field Visibility During Tympanomastoid Surgery in Adults A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The aim of this study is to evaluate the efficacy of adding dexamethasone to bupivacaine 025 in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery
Detailed Description:
Tympanomastoid surgery is a commonly performed otological procedure performed to treat various middle ear pathologies including chronic otitis media cholesteatoma and mastoiditis 1 One of the most significant complications associated with tympanomastoid surgery is bleeding which can result in surgical difficulties prolonged operative time and increased morbidity 2
Pain is also a major concern post-surgery and can lead to patient discomfort and dissatisfaction 3 Achieving optimal surgical field visibility is of paramount importance to ensure precise and safe surgical interventions However the presence of intraoperative bleeding and inadequate visualization can significantly impede the surgeons ability to perform the procedure effectively leading to potential complications and suboptimal outcomes 4
Conventional methods for pain management during tympanomastoid surgery often involve general anesthesia or local infiltration of anesthetic agents around the surgical site However these techniques may not adequately address pain control and can be associated with unwanted systemic side effects 5
To minimize bleeding and pain and improve surgical field visualization anesthetic techniques such as induced hypotension have been used to achieve adequate homeostasis and surgical field visualization during surgery 4
Induced hypotension involves reducing systemic blood pressure thereby decreasing blood flow to the surgical site minimizing the risk of bleeding and improving the surgical fields visualization leading to better surgical outcomes 5 However induced hypotension can lead to cerebral hypoperfusion organ damage and other serious complications 6
The use of regional anesthesia techniques such as ultrasound-guided superficial cervical plexus block SCPB has gained considerable attention as a potential adjunct to general anesthesia 7 SCPB block involves the deposition of local anesthetic agents around the superficial cervical plexus which provides sensory innervation to the ear mastoid and surrounding structures 8
The SCPB provides effective analgesia and reduces sympathetic activity resulting in reduced bleeding and improved surgical conditions 9 Also the superficial cervical plexus provides sensory innervation to the ear and surrounding structures reducing pain perception during and after surgery 10
Modern medicine focuses on enhancing patient outcomes and reducing surgical complications through improved surgical field visualization Advanced imaging technologies like intraoperative MRI or CT scanners offer real-time high-resolution images aiding accurate tumor localization 11 Fluorescence-guided agents like indocyanine green enhance visualization of blood vessels lymph nodes and tumors during surgery Augmented reality AR and virtual reality VR systems provide valuable guidance allowing surgeons to identify critical structures plan optimal incisions and simulate complex procedures pre-surgery Robot-assisted surgery offers enhanced precision and 3D visualization through high-definition cameras These combined methods lead to safer and more effective surgical interventions 12
Recent studies have suggested that combining bupivacaine a long-acting local anesthetic with dexamethasone a potent anti-inflammatory agent may offer several advantages 13 Bupivacaine provides prolonged pain relief while dexamethasone reduces local inflammation and edema potentially improving surgical field visibility 14
To our knowledge this is the first randomized clinical trial investigating the effect of adding dexamethasone to bupivacaine 025 in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery in adults
Pain is also a major concern post-surgery and can lead to patient discomfort and dissatisfaction 3 Achieving optimal surgical field visibility is of paramount importance to ensure precise and safe surgical interventions However the presence of intraoperative bleeding and inadequate visualization can significantly impede the surgeons ability to perform the procedure effectively leading to potential complications and suboptimal outcomes 4
Conventional methods for pain management during tympanomastoid surgery often involve general anesthesia or local infiltration of anesthetic agents around the surgical site However these techniques may not adequately address pain control and can be associated with unwanted systemic side effects 5
To minimize bleeding and pain and improve surgical field visualization anesthetic techniques such as induced hypotension have been used to achieve adequate homeostasis and surgical field visualization during surgery 4
Induced hypotension involves reducing systemic blood pressure thereby decreasing blood flow to the surgical site minimizing the risk of bleeding and improving the surgical fields visualization leading to better surgical outcomes 5 However induced hypotension can lead to cerebral hypoperfusion organ damage and other serious complications 6
The use of regional anesthesia techniques such as ultrasound-guided superficial cervical plexus block SCPB has gained considerable attention as a potential adjunct to general anesthesia 7 SCPB block involves the deposition of local anesthetic agents around the superficial cervical plexus which provides sensory innervation to the ear mastoid and surrounding structures 8
The SCPB provides effective analgesia and reduces sympathetic activity resulting in reduced bleeding and improved surgical conditions 9 Also the superficial cervical plexus provides sensory innervation to the ear and surrounding structures reducing pain perception during and after surgery 10
Modern medicine focuses on enhancing patient outcomes and reducing surgical complications through improved surgical field visualization Advanced imaging technologies like intraoperative MRI or CT scanners offer real-time high-resolution images aiding accurate tumor localization 11 Fluorescence-guided agents like indocyanine green enhance visualization of blood vessels lymph nodes and tumors during surgery Augmented reality AR and virtual reality VR systems provide valuable guidance allowing surgeons to identify critical structures plan optimal incisions and simulate complex procedures pre-surgery Robot-assisted surgery offers enhanced precision and 3D visualization through high-definition cameras These combined methods lead to safer and more effective surgical interventions 12
Recent studies have suggested that combining bupivacaine a long-acting local anesthetic with dexamethasone a potent anti-inflammatory agent may offer several advantages 13 Bupivacaine provides prolonged pain relief while dexamethasone reduces local inflammation and edema potentially improving surgical field visibility 14
To our knowledge this is the first randomized clinical trial investigating the effect of adding dexamethasone to bupivacaine 025 in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery in adults
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