General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries

Study Overview
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Brief Summary
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Background: Proper selection of anesthetic technique is important in middle ear microsurgery. Controlled hypotension in ear surgery decreases blood loss with improved quality of the surgical field, however, it is associated with resistance to vasodilators and delayed recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and head-neck position had been reported with the increased risk of patient injuries. This study aimed to compare the effects of local ear block combined with general anesthesia versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic consumption, recovery characteristics, postoperative pain, adverse effects and postoperative complications.

Detailed Description
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Eighty adult patients undergoing middle ear surgery (tympanoplasty with or without mastoidectomy) were enrolled in the study. Patients were randomized into two equal groups (40 patients each). A standardized general anesthetic technique was used in both groups. Group I, received general anesthesia combined with ear block using 10 ml of 0.25% bupivacaine and (Group II), received general anesthesia alone combined with ear block using 10 ml saline. Propofol 2-3 mg /Kg was administered to induce anesthesia, which was maintained using isoflurane. Hemodynamic variables, surgical conditions including the quality of the operative field, intraoperative fentanyl, vasodilators (propranolol and nitroglycerine), isoflurane consumption, recovery time, postoperative pain, total analgesics consumption and postoperative complications were recorded

Official Title
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General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial

Conditions
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Tympanum; Perforation

Intervention / Treatment
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* Drug: local anaesthetic injection
* Drug: Normal Saline Flush, 0.9% Injectable Solution
* Drug: general anesthetic
* Drug: Hypotensives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or II status, scheduled for tympanoplasty with or without mastoidectomy Exclusion Criteria: patient refusal, known allergy to local anesthetics cardiovascular diseases (myocardial infarction, hypertension and valvular heart diseases) --- cerebrovascular diseases (including transient ischemic attacks), renal, hepatic insufficiency or coagulation abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group l<br>ear block by local anaesthetic injection 0.25% bupivacaine. general anesthetic by: midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 µg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol | Drug: local anaesthetic injection<br>* ear block by 0.25% bupivacaine<br>* Other names: 0.25% bupivacaine;Drug: general anesthetic<br>* general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.<br>* Other names: general anesthesia;Drug: Hypotensives<br>* hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol<br>* Other names: deliberate hypotension;|
| Placebo Comparator: Group II<br>ear block by Normal Saline Flush, 0.9% Injectable Solution . general anesthetic by: midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 µg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol | Drug: Normal Saline Flush, 0.9% Injectable Solution<br>* ear block by Normal Saline Flush, 0.9% Injectable Solution<br>* Other names: saline ear block;Drug: general anesthetic<br>* general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.<br>* Other names: general anesthesia;Drug: Hypotensives<br>* hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol<br>* Other names: deliberate hypotension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure | mean arterial blood pressure in mmHg | at arrival to the operating room,1 minute after induction of anesthesia,1 minute after surgical incision,then every 15 minutes till the time of complete surgical wound closure. - postoperative every one hour for 4 hours then every 4 hours for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate in beats /minute | at arrival to the operating room,1 minute after induction of anesthesia,1 minute after surgical incision,then every 15 minutes till the time of complete surgical wound closure. - postoperative every one hour for 4 hours then every 4 hours for 24 hours | 
| quality of the operative field | four-point scale from 0=no bleeding (excellent surgical conditions), 1=minimum bleeding (sporadic suction), 2= diffuse bleeding (repeated suction), and 3=abundant (troublesome) bleeding | every 15 minutes from start of the surgical incision till the time of complete surgical wound closure. | 
| recovery time | the time from cessation of all anesthetics until complete recovery using the Aldrete's score | time from stopping of all anesthetics till the patient had Aldrete's score of 9. | 
| postoperative pain | measured by visual analogue scale (from 0 no pain to10 worst imaginable pain) | postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours. | 
| total analgesic consumption | ketorolac consumption in mg | in the first 24 hours postoperative | 
| nitroglycerine consumption | total nitroglycerine consumption in ug | during the operation time | 
| propranolol consumption | total propranolol consumption in mg | during the operation time | 
| nausea | the number of patients who developed nausea | in the first 24 hours postoperative | 
| vomiting | the number of patients who developed vomiting | in the first 24 hours postoperative | 
| headache | the number of patients who developed headache | in the first 24 hours postoperative | 
| facial palsy | the number of patients who developed facial palsy | in the first 24 hours postoperative |