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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-06

Study Completion Date

2018-12-30

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.

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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

Conditions

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Tympanum; Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The same surgeons performed all the operations to ensure consistency in the estimation of the surgical field. To eliminate the observer bias, the observing anesthetist did not attend the induction of block. Also, the operating surgeon was blinded to the pharmacological treatments, anesthesia and performance of the used techniques.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

local anaesthetic injection

Intervention Type DRUG

ear block by 0.25% bupivacaine

general anesthetic

Intervention Type DRUG

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

Intervention Type DRUG

hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol

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

Group Type PLACEBO_COMPARATOR

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type DRUG

ear block by Normal Saline Flush, 0.9% Injectable Solution

general anesthetic

Intervention Type DRUG

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

Intervention Type DRUG

hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol

Interventions

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local anaesthetic injection

ear block by 0.25% bupivacaine

Intervention Type DRUG

Normal Saline Flush, 0.9% Injectable Solution

ear block by Normal Saline Flush, 0.9% Injectable Solution

Intervention Type 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.

Intervention Type DRUG

Hypotensives

hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol

Intervention Type DRUG

Other Intervention Names

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0.25% bupivacaine saline ear block general anesthesia deliberate hypotension

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No