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Sphenopalatine Ganglion Block for Nasal Surery

Primary Purpose

Intraoperative Bleeding, Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.5% Preservative-Free Injectable Solution
normal saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Bleeding

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patient refusal
  • emergency surgery

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bupivacaine group

saline group

Arm Description

Outcomes

Primary Outcome Measures

Postoperative emergence agitation
i
intraoperative bleeding

Secondary Outcome Measures

postoperative opioid consumption

Full Information

First Posted
November 16, 2019
Last Updated
October 6, 2023
Sponsor
Assiut University
Collaborators
saeid metwaly abouelyazid elsawy
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1. Study Identification

Unique Protocol Identification Number
NCT04168879
Brief Title
Sphenopalatine Ganglion Block for Nasal Surery
Official Title
Efficacy of Intranasal Approach of Sphenopalatine Ganglion Block for Nasal Surery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
saeid metwaly abouelyazid elsawy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding, Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bupivacaine group
Arm Type
Active Comparator
Arm Title
saline group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% Preservative-Free Injectable Solution
Intervention Description
1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used transnasally to block the sphenopalatine ganglion
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion
Primary Outcome Measure Information:
Title
Postoperative emergence agitation
Description
i
Time Frame
2 hour
Title
intraoperative bleeding
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
postoperative opioid consumption
Time Frame
2 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient written consent elective surgery age 18 - 40 year old Exclusion Criteria: patient refusal emergency surgery
Facility Information:
Facility Name
Faculty of Medicine
City
Asyut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sphenopalatine Ganglion Block for Nasal Surery

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