Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381401
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-19
Brief Title:
Bupivacaine 0125 Versus Bupivacaine 025 in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Efficacy of Bupivacaine 0125 Versus Bupivacaine 025 in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries A Prospective Randomized Controlled Study
Status:
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:
Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity Pain is also one of the most annoying complications of tympanomastoid surgeries Thus adequate surgical field visualization is utmost important A bloodless field allows optimal exposure and identification of vital neurovascular structures Even small bleeding inconsequential for the patients volume status can create great technical difficulty in the confined space of the tympan leading to prolonged surgery incomplete procedures and increased complications
The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years The superficial cervical plexus block SCPB provides effective analgesia and reduces sympathetic activity resulting in reduced bleeding and improved surgical conditions The superficial cervical plexus SCP provides sensory innervation to the ear and surrounding structures reducing pain perception during and after surgery
This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0125 versus 025 bupivacaine during tympanomastoid surgery
This study aims to compare the efficacy of two different concentrations of bupivacaine 0125 025 in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization intraoperative hemodynamic stability and postoperative analgesia
The investigators hypothesize that bupivacaine 0125 would be non-inferior to bupivacaine 025 in achieving optimal surgical field visualization hemodynamic stability surgeon satisfaction and postoperative analgesia
This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years with ASA I-II and undergoing tympanomastoid surgery Participants were equally divided into two groups Group A Patients received SCPB using 025 bupivacaine 5ml of bupivacaine 05 5ml normal saline Group B Patients received SCPB using 0125 bupivacaine 25ml of bupivacaine 05 75ml normal saline
The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years The superficial cervical plexus block SCPB provides effective analgesia and reduces sympathetic activity resulting in reduced bleeding and improved surgical conditions The superficial cervical plexus SCP provides sensory innervation to the ear and surrounding structures reducing pain perception during and after surgery
This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0125 versus 025 bupivacaine during tympanomastoid surgery
This study aims to compare the efficacy of two different concentrations of bupivacaine 0125 025 in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization intraoperative hemodynamic stability and postoperative analgesia
The investigators hypothesize that bupivacaine 0125 would be non-inferior to bupivacaine 025 in achieving optimal surgical field visualization hemodynamic stability surgeon satisfaction and postoperative analgesia
This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years with ASA I-II and undergoing tympanomastoid surgery Participants were equally divided into two groups Group A Patients received SCPB using 025 bupivacaine 5ml of bupivacaine 05 5ml normal saline Group B Patients received SCPB using 0125 bupivacaine 25ml of bupivacaine 05 75ml normal saline
Detailed Description:
None
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