Sphenopalatine Ganglion Block for Nasal Surery

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04168879

Collaborator

saeid metwaly abouelyazid elsawy (Other)

Enrollment

Location

Arms

12.7

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Bleeding Postoperative Delirium	Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution Drug: normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Efficacy of Intranasal Approach of Sphenopalatine Ganglion Block for Nasal Surery

Actual Study Start Date :

Nov 10, 2019

Anticipated Primary Completion Date :

Nov 10, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

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 transnasally to block the sphenopalatine ganglion
Placebo Comparator: saline group	Drug: normal saline 1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion

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 transnasally to block the sphenopalatine ganglion

Placebo Comparator: saline group

Drug: normal saline

1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion

Outcome Measures

Primary Outcome Measures

intraoperative bleeing [2 hour]
intraoperative bleeing will be assessed by counting and weigheing the used intraoperative gauzes
postoperative emergence agitation [24 hours]
postoperative emergence agitation will be measured by Riker Sedation-Agitation Scale (SAS) . the scale has seven grades, 1 mean unarousable and 7 means dangerously agitated. score 5 and more indicates emergence agitation

Secondary Outcome Measures

intraoperative anaesthetic consumption [2 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient written consent
elective surgery
age 18 - 40 year old

Exclusion Criteria:

patient refusal
emergency surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Asyut		Egypt	71111

Sponsors and Collaborators

Assiut University
saeid metwaly abouelyazid elsawy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rasha Hamed, lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT04168879

Other Study ID Numbers:

ACCA

First Posted:

Nov 19, 2019

Last Update Posted:

Nov 19, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Blood Loss, Surgical

Bupivacaine

Study Results

No Results Posted as of Nov 19, 2019