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

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

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.

Study Overview

• Status: Completed
• Conditions: Tympanum; Perforation
• Intervention / Treatment: Drug: local anaesthetic injection; Drug: general anesthetic; Drug: Hypotensives; Drug: Normal Saline Flush, 0.9% Injectable Solution

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shebin El-kom
    • Cairo, Shebin El-kom, Egypt, 32511
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: group l; 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; ear block by 0.25% bupivacaine; Other Names: 0.25% bupivacaine; Drug: general anesthetic; 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.; Other Names: general anesthesia; Drug: Hypotensives; hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol; Other Names: deliberate hypotension
PLACEBO_COMPARATOR: Group II; 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: general anesthetic; 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.; Other Names: general anesthesia; Drug: Hypotensives; hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol; Other Names: deliberate hypotension; Drug: Normal Saline Flush, 0.9% Injectable Solution; ear block by Normal Saline Flush, 0.9% Injectable Solution; Other Names: saline ear block

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abd-Elazeem Abd-Elhameed Elbakry
• Investigators: Study Director: Abd-Elazeem A Elbakry, M.D, Assistant professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2018
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antihypertensive Agents; Anesthetics, Local; Bupivacaine; Anesthetics, General
• Other Study ID Numbers: 2017/12/8/8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No