NCT05854537

Brief Summary

Patients will be divided into 2 groups, 30 each. Group A will receive sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils then by local anesthetic injected by a cannula into both nostrils. Group B will undergo the same procedure, but normal saline will be used instead of the local anesthetic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

April 21, 2023

Last Update Submit

January 31, 2024

Conditions

Postoperative Pain

Keywords

Sphenopalatine ganglion blockBlood lossPain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Postoperative pain will be assessed by the Visual Analog Score (VAS) after 6 hours, the (VAS) is a scale from 1 to 10 where 1 is the least pain and 10 is the worst pain

    6 hours postoperative

Secondary Outcomes (2)

  • Intraoperative opioid consumption

    4 hours

  • Blood loss

    4 hours

Study Arms (2)

Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries

ACTIVE COMPARATOR

Patients will have the cotton swab soaked in the LA medication (bupivacaine: lidocaine) introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally.

Procedure: Sphenopalatine ganglion block using bupivacaine: xylocaine

Sphenopalatine ganglion block using normal saline for maxillofacial surgeries

PLACEBO COMPARATOR

Patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will be done by normal saline as well.

Procedure: Sphenopalatine ganglion block using normal saline

Interventions

Sphenopalatine ganglion block using bupivacaine: xylocainePROCEDURE

Patients will have the cotton swab soaked in the LA medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally.

Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries
Sphenopalatine ganglion block using normal salinePROCEDURE

Patients will have the cotton swab soaked in normal saline introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication, and then they will have 1.5 ml normal saline injected via a syringe connected to a 20G catheter into their nostrils bilaterally.

Sphenopalatine ganglion block using normal saline for maxillofacial surgeries

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18 and 60 years undergoing maxillofacial surgeries

You may not qualify if:

  • Patient refusal
  • Patients with fracture nose
  • Operation time of more than 4 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11728, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeHemorrhagePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sameh Refaat

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 11, 2023

Study Start

March 20, 2023

Primary Completion

December 4, 2023

Study Completion

December 27, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

EG(1)