Sphenopalatine Ganglion Block for Nasal Surery

Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery

nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Intraoperative Bleeding
• Intervention / Treatment: Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71111
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient written consent
• elective surgery
• age 18 - 40 year old

Exclusion Criteria:

• patient refusal
• emergency surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine group	Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution; 1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach
Placebo Comparator: saline group	Drug: normal saline; 1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative emergence agitation	ramsy hunt sedation agitation score used during emergence from anesthesia	2 hour
intraoperative bleeding	suction and weight of surgical gauze used was measured and calculated	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative opioid consumption	total amount of opioid analgesia in first 24 hours postoperative	24 hour
surgical field quality	Boezaart score was be used	2 hours
consumed inhalational anesthesia	mean anesthesia MAC intraoperative	2 hours
postoperative pain	using VAS ; scale from 0 to 10 . where 0 is no pain and 10 is worst pain	2 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: saeid metwaly abouelyazid elsawy

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Hemorrhage; Intraoperative Complications; Delirium; Emergence Delirium; Blood Loss, Surgical; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ACCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No