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Completed

NCT Number: NCT03569046

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

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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Key information

Conditions

Tympanum; Perforation Ear Diseases Otorhinolaryngologic Diseases Tympanic Membrane Perforation Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

local anaesthetic injection

Drug

ear block by 0.25% bupivacaine

Other names: 0.25% bupivacaine

Normal Saline Flush, 0.9% Injectable Solution

Drug

ear block by Normal Saline Flush, 0.9% Injectable Solution

Other names: saline ear block

General anesthetic

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.

Other names: general anesthesia

Hypotensives

Drug

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

Other names: deliberate hypotension

Primary outcomes

  1. mean arterial blood pressure

    Time frame: 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 outcomes

  1. heart rate

    Time frame: 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

  2. quality of the operative field

    Time frame: 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

  3. recovery time

    Time frame: 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

  4. postoperative pain

    Time frame: 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")

  5. total analgesic consumption

    Time frame: in the first 24 hours postoperative

    ketorolac consumption in mg

  6. nitroglycerine consumption

    Time frame: during the operation time

    total nitroglycerine consumption in ug

  7. propranolol consumption

    Time frame: during the operation time

    total propranolol consumption in mg

  8. nausea

    Time frame: in the first 24 hours postoperative

    the number of patients who developed nausea

  9. vomiting

    Time frame: in the first 24 hours postoperative

    the number of patients who developed vomiting

  10. headache

    Time frame: in the first 24 hours postoperative

    the number of patients who developed headache

  11. facial palsy

    Time frame: in the first 24 hours postoperative

    the number of patients who developed facial palsy

Sponsors and collaborators

Lead sponsor

Abd-Elazeem Abd-Elhameed Elbakry

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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