Dexamethasone vs Dexmedetomidine in Sphenopalatine Ganglion Block for Rhinoplasty Pain

Dexamethasone Versus Dexmedetomidine as Adjuvant to Bupivacaine in Sphenopalatine Ganglion Block as Post-operative Analgesia in Rhinoplasty Surgeries

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bubpivacaine; Drug: Dexamedomedine; Drug: Dexamethasone

Detailed Description

Preoperative settings:

Preoperative evaluation of full medical history will be taken, examination will be done, and routine preoperative investigations will be done to all patients including complete blood picture and coagulation profile.

The patient will be fasting for at least 8 hours preoperatively

Intraoperative settings:

General anesthesia technique:

Upon arrival to OR, Standard monitoring will be applied: ECG, non-invasive blood pressure and pulse oximeter, Intravenous access (20G) will be inserted, and all patients will receive midazolam 0.05mg/kg IV for anxiety, ranitidine 50 mg IV and ondansetron 0.15mg/kg IV 15 min before induction.

Induction of anesthesia in all groups will be done by intravenous propofol 2-2.5 mg/kg IV, fentanyl 1 µg/kg IV and atracurium 0.5 mg/kg IV, then endotracheal tube of suitable size will be applied and capnogram will be connected. Maintenance will be achieved by isoflurane inhalation started with 1.2 % and top-up doses of atracurium (0.01 mg/kg IV). Volume controlled positive pressure ventilation was adjusted at tidal volume and respiratory rate to keep ETCO2 at 35-40 mmHg with continuous monitoring. During surgery, the patients received intravenous infusion of ringer solution according to fluid requirement regimen. Fluid administration will be guided by hemodynamics monitoring and clinical parameters

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11122
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B; Group B (control group): will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).	Drug: Bubpivacaine; will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).
Active Comparator: Group BDX; Group BDX: will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.	Drug: Dexamedomedine; will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.
Active Comparator: Group BD; Group BD: will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline	Drug: Dexamethasone; will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: FMASU MD255/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No