Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries

Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial

Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).

Study Overview

• Status: Completed
• Conditions: Agitation States as Acute Reaction to Gross Stress
• Intervention / Treatment: Procedure: External nasal nerve block; Drug: saline adrenaline; Drug: Xylocaine, adrenaline

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Meccah
    • Jeddah, Meccah, Saudi Arabia, 21462/7500
      • Al Jedaani group of hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 110 adult patients of ASA physical status I and II,
• Age 20-60 years,
• Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.

Exclusion Criteria:

1. History of uncontrolled hypertension,
2. Ischemic or valvular heart disease,
3. Use of MAO inhibitors or adrenergic blocking drugs,
4. Cognitive impairment,
5. Patients taking antipsychotics,
6. Renal insufficiency or liver dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I(control); patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)	Procedure: External nasal nerve block; Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.; Drug: saline adrenaline
Active Comparator: Group II(block); 'External nasal nerve block by Xylocaine, adrenaline'	Procedure: External nasal nerve block; Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.; Drug: Xylocaine, adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative agitation	Assessment done using Richmond agitation- sedation scale (RASS)	Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Quality of recovery	Quality of recovery	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dose of fentanyl	Fentanyl boluses were given in response to changes in hemodynamics (more than 15% increases in MAP and HR than the baseline values taken after induction by 5 minutes)	intraoperative period in minutes
morphine dose in PACU	equivalent morphine dose in PACU (calculated using opioid:morphine equivalents of 100 µg i.v. fentanyl to 10 mg i.v. morphine; 75- 100 mg IV pethidine to 10 mg i.v. morphine	one hour in PACU
Nausea and vomiting in PACU	Four-point nausea and vomiting scale (0=no nausea; 1=mild nausea; 2=severe nausea requiring antiemetics; and 3=retching, vomiting, or both) was also evaluated	one hour in PACU
Extubation time		Up to 15 after discontinuation of anesthesia
Surgical time	intraoperative	duration of surgery in minutes up to 3 hours
first verbal response time	period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes	up to 15 minutes
complication of nasal block	including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.	From injection to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Al Jedaani Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 23, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Nasal surgery; external nasal nerve block; postoperative agitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 3-2-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided