NCT07380139

Brief Summary

This study will test the effect of adding dexamethasone versus dexmedetomidine as adjuvants to bupivacaine in sphenopalatine ganglion block used for pain after rhinoplasty

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 24, 2026

Last Update Submit

January 24, 2026

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • The time to the first request of analgesia

    The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia

    9 months

Study Arms (3)

Group B

ACTIVE COMPARATOR

Group B (control group): will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).

Drug: Bubpivacaine

Group BDX

ACTIVE COMPARATOR

Group BDX: will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.

Drug: Dexamedomedine

Group BD

ACTIVE COMPARATOR

Group BD: will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline

Drug: Dexamethasone

Interventions

DexamedomedineDRUG

will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.

Group BDX
DexamethasoneDRUG

will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline

Group BD
BubpivacaineDRUG

will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).

Group B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years.
  • Sex: of either sex.
  • American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
  • BMI \< 35
  • Scheduled for rhinoplasty surgeries under general anaesthesia.

You may not qualify if:

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
  • Psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11122, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

EG(1)