protocolSection identificationModule nctId: NCT06381401, orgStudyIdInfo id: MS-492-2023, briefTitle: Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: 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 patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious 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.To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline)., conditionsModule conditions: Surgical Field Visualization, Acute Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: bupivacaine 0.25%, interventions name: bupivacaine 0.125%, outcomesModule primaryOutcomes measure: The total consumption of IV glyceryl trinitrate (GTN), secondaryOutcomes measure: Fentanyl consumption, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative hospital stay, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False