Post Operative PainPhase 1NCT07380139
Dexamethasone vs Dexmedetomidine in Sphenopalatine Ganglion Block for Rhinoplasty Pain
A Phase 1 study testing Dexamedomedine, Dexamethasone and Bubpivacaine in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Dexamedomedine, Dexamethasone and Bubpivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Conditions
- Post Operative Pain
- Being tested
- Dexamedomedine, Dexamethasone, Bubpivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamedomedineDrug
will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.
DexamethasoneDrug
will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline
BubpivacaineDrug
will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Group B (control group): will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml). Receives: 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. Receives: Drug: Dexamedomedine |
| Group BD | Active comparator | Group BD: will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380139
- Sponsor's protocol ID
- FMASU MD255/2025
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Versus Dexmedetomidine as Adjuvant to Bupivacaine in Sphenopalatine Ganglion Block as Post-operative Analgesia in Rhinoplasty Surgeries
- ClinicalTrials.gov ID
- NCT07380139
- Acronym / sponsor ID
- FMASU MD255/2025
- Conditions
- Post Operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effect of adding dexamethasone versus dexmedetomidine as adjuvants to bupivacaine in sphenopalatine ganglion block used for pain after rhinoplasty
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Drug: BubpivacaineGroup B (control group): will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml). |
| Group BDX | Active comparator | Drug: DexamedomedineGroup BDX: will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline. |
| Group BD | Active comparator | Drug: DexamethasoneGroup BD: will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamedomedinewill receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline. | Drug | Group BDX |
| Dexamethasonewill receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline | Drug | Group BD |
| Bubpivacainewill receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml). | Drug | Group B |
Primary outcome
The time to the first request of analgesia
Time frame: 9 months
The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamedomedine, Dexamethasone and Bubpivacaine in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to the first request of analgesia (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.