Clinical trial NCT03569046: General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
Official title: General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tympanum; Perforation
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: 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 outcomes:
measure: heart rate
timeFrame: 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
measure: quality of the operative field
timeFrame: every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.
measure: recovery time
timeFrame: time from stopping of all anesthetics till the patient had Aldrete's score of 9.
measure: postoperative pain
timeFrame: postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.
measure: total analgesic consumption
timeFrame: in the first 24 hours postoperative
measure: nitroglycerine consumption
timeFrame: during the operation time
measure: propranolol consumption
timeFrame: during the operation time
measure: nausea
timeFrame: in the first 24 hours postoperative
measure: vomiting
timeFrame: in the first 24 hours postoperative
measure: headache
timeFrame: in the first 24 hours postoperative
measure: facial palsy
timeFrame: in the first 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Shebin El-kom
Study officials:
affiliation: Assistant professor
name: Abd-Elazeem A Elbakry, M.D
role: STUDY_DIRECTOR
References: