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

Not Applicable

Completed

• Conditions: Tympanum; Perforation
• Interventions: Drug: local anaesthetic injection; Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: general anesthetic; Drug: Hypotensives

• Registration Number: NCT03569046
• Lead Sponsor: Abd-Elazeem Abd-Elhameed Elbakry

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-26
• Study Start: 2018-07-06
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group l	local anaesthetic injection	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
Group II	general anesthetic	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
group l	general anesthetic	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
group l	Hypotensives	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
Group II	Normal Saline Flush, 0.9% Injectable Solution	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
Group II	Hypotensives	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

Primary Outcome Measures

Name	Time	Method
mean arterial blood pressure	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	mean arterial blood pressure in mmHg

Secondary Outcome Measures

Name	Time	Method
headache	in the first 24 hours postoperative	the number of patients who developed headache
nitroglycerine consumption	during the operation time	total nitroglycerine consumption in ug
propranolol consumption	during the operation time	total propranolol consumption in mg
vomiting	in the first 24 hours postoperative	the number of patients who developed vomiting
heart rate	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	heart rate in beats /minute
recovery time	time from stopping of all anesthetics till the patient had Aldrete's score of 9.	the time from cessation of all anesthetics until complete recovery using the Aldrete's score
postoperative pain	postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.	measured by visual analogue scale (from 0 "no pain" to10 "worst imaginable pain")
total analgesic consumption	in the first 24 hours postoperative	ketorolac consumption in mg
nausea	in the first 24 hours postoperative	the number of patients who developed nausea
facial palsy	in the first 24 hours postoperative	the number of patients who developed facial palsy
quality of the operative field	every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.	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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Cairo, Shebin El-kom, Egypt