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

Tympanum; Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569046
• Other study ID #: 2017/12/8/8
• Status: Completed
• Phase: N/A
• Start date: July 6, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tympanic Membrane Perforation
• Tympanum; Perforation

Intervention

Drug:
• local anaesthetic injection
ear block by 0.25% bupivacaine
• Normal Saline Flush, 0.9% Injectable Solution
ear block by Normal Saline Flush, 0.9% Injectable Solution
• 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.
• Hypotensives
hypotensives for deliberate hypotension by nitroglycerine 0.5-10 µg /kg/min and increments of 0.2 mg propranolol

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Abd-Elazeem Abd-Elhameed Elbakry

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	total analgesic consumption	ketorolac consumption in mg	in the first 24 hours postoperative
Secondary	nitroglycerine consumption	total nitroglycerine consumption in ug	during the operation time
Secondary	propranolol consumption	total propranolol consumption in mg	during the operation time
Secondary	nausea	the number of patients who developed nausea	in the first 24 hours postoperative
Secondary	vomiting	the number of patients who developed vomiting	in the first 24 hours postoperative
Secondary	headache	the number of patients who developed headache	in the first 24 hours postoperative
Secondary	facial palsy	the number of patients who developed facial palsy	in the first 24 hours postoperative