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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03069027
Enrollment
100
Registered
2017-03-03
Start date
2016-08-15
Completion date
2017-07-01
Last updated
2017-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation States as Acute Reaction to Gross Stress

Keywords

Nasal surgery, external nasal nerve block, postoperative agitation

Brief summary

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).

Interventions

PROCEDUREExternal nasal nerve block

Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.

DRUGsaline adrenaline
DRUGXylocaine, adrenaline

Sponsors

Al Jedaani Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative agitationEmergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.Assessment done using Richmond agitation- sedation scale (RASS)
Quality of recovery24 hours postoperativeQuality of recovery

Secondary

MeasureTime frameDescription
Nausea and vomiting in PACUone hour in PACUFour-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
Extubation timeUp to 15 after discontinuation of anesthesia
dose of fentanylintraoperative period in minutesFentanyl 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)
first verbal response timeup to 15 minutesperiod from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
complication of nasal blockFrom injection to 24 hours postoperativeincluding local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.
Surgical timeduration of surgery in minutes up to 3 hoursintraoperative
morphine dose in PACUone hour in PACUequivalent 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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026