Post Operative PainPhase 4NCT07911202
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
A Phase 4 study testing Bupivacaine & normal saline, Dexmedetomidine & Bupivacaine. and Dexamethasone & Bupivacaine. in people with Post Operative Pain and Emergence Agitation, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective, randomized, double-blind, controlled trial will compare the efficacy and safety of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided bilateral sphenopalatine ganglion block for adult patients (18-60 years, ASA I-II) undergoing elective functional endoscopic sinus… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Emergence Agitation, Functional Endoscopic Sinus Surgery
- What is being tested?
- Bupivacaine & normal saline, Dexmedetomidine & Bupivacaine. and Dexamethasone & Bupivacaine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to May 2027
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Elective FESS under general anesthesia.
- ASA Physical Status I-II
Who cannot join
- Allergy to local anesthetics
- Coagulopathy or use of anticoagulants
- Anatomical nasal deformities obstructing access
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university hospital
Sohag, Sohag Governorate
Nardin Ehab Halim, MBBCH, 01012631360, nardinehab12@gmail.com
About this study
Official title: Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block in Patients Undergoing Functional Endoscopic Sinus Surgery
This prospective, randomized, double-blind, controlled trial will compare the efficacy and safety of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided bilateral sphenopalatine ganglion block for adult patients (18-60 years, ASA I-II) undergoing elective functional endoscopic sinus surgery (FESS) under general anesthesia. Participants will be randomly allocated in a 1:1:1 ratio to receive bupivacaine alone, bupivacaine plus dexmedetomidine, or bupivacaine plus dexamethasone. The study will assess postoperative pain scores, duration of analgesia, total analgesic consumption, and intraoperative hemodynamic parameters, in addition to adverse effects.
Read the detailed description
Background: Postoperative pain after functional endoscopic sinus surgery (FESS) is often significant, and conventional management relies on opioids and NSAIDs, which carry potential side effects. Ultrasound-guided sphenopalatine ganglion block (SPGB) with bupivacaine provides regional analgesia, but its duration may be insufficient. Dexmedetomidine and dexamethasone are adjuvants known to prolong analgesia and reduce analgesic requirements, yet direct comparative evidence for ultrasound-guided SPGB in FESS is limited.
Design: Prospective, randomized, double-blind, controlled clinical trial conducted at the ENT department, Sohag University Hospital. Eligible patients (age 18-60 years, ASA I-II, elective FESS under general anesthesia) who provide written informed consent will be randomized 1:1:1 using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes. Patients with allergy to local anesthetics, coagulopathy or anticoagulant use, anatomical nasal deformities obstructing access, or who refuse participation will be excluded.
Interventions: All patients will receive ultrasound-guided bilateral SPGB with a total volume of 10 mL (5 mL per side) after induction of general anesthesia.
- Group A (control): 8 mL bupivacaine 0.5% plus 2 mL normal saline.
- Group B: 8 mL bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL.
- Group C: 8 mL bupivacaine 0.5% plus dexamethasone 8 mg (2 mL).
Patients, anesthesiologists responsible for intraoperative and postoperative assessment, surgeons, and data analysts will be blinded to group allocation.
Anesthetic technique: General anesthesia will be induced with propofol 2.5 mg/kg and fentanyl 1 µg/kg, and intubation facilitated with atracurium 0.5 mg/kg. Anesthesia will be maintained with isoflurane in oxygen and atracurium boluses, with mechanical ventilation to keep end-tidal CO2 at 35-45 mmHg.
Outcomes: Postoperative pain scores, duration of analgesia, total analgesic consumption, intraoperative hemodynamic measurements, and adverse effects.
- Being tested
- Bupivacaine & normal saline, Dexmedetomidine & Bupivacaine., Dexamethasone & Bupivacaine.
- Keywords
- sphenopalatine ganglion block, Dexmedetomidine, Dexamethasone, Bupivacaine, postoperative analgesia
- Medical subject headings
- Pain, Postoperative, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine & normal salineDrug
2 mL of normal saline 0.9% added to bupivacaine 0.5% (8 mL) in the sphenopalatine ganglion block to maintain a total volume of 10 mL (5 mL per side) and ensure blinding.
Dexmedetomidine & Bupivacaine.Drug
Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline 0.9% to a volume of 2 mL, giving a total volume of 10 mL (5 mL per side)
Dexamethasone & Bupivacaine.Drug
Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Bupivacaine | Active comparator | Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus 2 mL of normal saline, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. Receives: Drug: Bupivacaine & normal saline |
| Group B: Bupivacaine + Dexmedetomidine | Experimental | Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| Group C: Bupivacaine + Dexamethasone | Experimental | Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. Receives: Drug: Dexamethasone & Bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be compared among the three study groups.Unit of measure : score on a scale
Measured: At PACU arrival and at 2, 4, 6, 12, and 24 hours postoperatively
Secondary outcomes (5)
Time to First Rescue Analgesia
The time from the end of surgery to the first postoperative rescue analgesic request or administration. Unit of measure: minutes.
Measured: From the end of surgery until the first rescue analgesic dose, within the first 24 hours postoperatively.
Incidence of Emergence Agitation
Emergence agitation is defined as a Richmond Agitation-Sedation Scale (RASS) score of +1 or higher. The number of participants with emergence agitation will be reported. Unit of measure: number of participants.
Measured: During emergence from general anesthesia and at PACU arrival
Intraoperative Mean Arterial Pressure
Mean arterial pressure (MAP) will be recorded at baseline, after induction of general anesthesia, and every 10 minutes intraoperatively until the end of surgery. Unit of measure: mmHg.
Measured: From baseline assessment before induction of general anesthesia until the end of surgery
Intraoperative Heart Rate
Heart rate (HR) will be recorded at baseline, after induction of general anesthesia, and every 10 minutes intraoperatively until the end of surgery. Unit of measure: beats per minute.
Measured: From baseline before induction of general anesthesia until the end of surgery.
Number of Postoperative Rescue Analgesic Doses
The total number of postoperative rescue analgesic doses administered, regardless of drug type, during the first 24 hours after surgery.Unit of measure: number of doses
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 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 Sohag 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, three-arm, randomized, double-blind controlled trial. Eligible patients undergoing elective functional endoscopic sinus surgery will be randomly allocated in a 1:1:1 ratio to one of three groups, each receiving ultrasound-guided bilateral sphenopalatine ganglion block (10 mL total, 5 mL per side): Group A (bupivacaine 0.5% plus normal saline), Group B (bupivacaine 0.5% plus dexmedetomidine 1 µg/kg), or Group C (bupivacaine 0.5% plus dexamethasone 8 mg). Each patient remains in the assigned group throughout the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardin Ehab Halim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911202
- Sponsor's protocol ID
- Soh-Med-26-10-12MS
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block in Patients Undergoing Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07911202
- Acronym / sponsor ID
- Soh-Med-26-10-12MS
- Keywords
- sphenopalatine ganglion block, Dexmedetomidine, Dexamethasone, Bupivacaine, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Nov 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 prospective, randomized, double-blind, controlled trial will compare the efficacy and safety of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided bilateral sphenopalatine ganglion block for adult patients (18-60 years, ASA I-II) undergoing elective functional endoscopic sinus surgery (FESS) under general anesthesia. Participants will be randomly allocated in a 1:1:1 ratio to receive bupivacaine alone, bupivacaine plus dexmedetomidine, or bupivacaine plus dexamethasone. The study will assess postoperative pain scores, duration of analgesia, total analgesic consumption, and intraoperative hemodynamic parameters, in addition to adverse effects.
Detailed description
Background: Postoperative pain after functional endoscopic sinus surgery (FESS) is often significant, and conventional management relies on opioids and NSAIDs, which carry potential side effects. Ultrasound-guided sphenopalatine ganglion block (SPGB) with bupivacaine provides regional analgesia, but its duration may be insufficient. Dexmedetomidine and dexamethasone are adjuvants known to prolong analgesia and reduce analgesic requirements, yet direct comparative evidence for ultrasound-guided SPGB in FESS is limited.
Design: Prospective, randomized, double-blind, controlled clinical trial conducted at the ENT department, Sohag University Hospital. Eligible patients (age 18-60 years, ASA I-II, elective FESS under general anesthesia) who provide written informed consent will be randomized 1:1:1 using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes. Patients with allergy to local anesthetics, coagulopathy or anticoagulant use, anatomical nasal deformities obstructing access, or who refuse participation will be excluded.
Interventions: All patients will receive ultrasound-guided bilateral SPGB with a total volume of 10 mL (5 mL per side) after induction of general anesthesia.
- Group A (control): 8 mL bupivacaine 0.5% plus 2 mL normal saline.
- Group B: 8 mL bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL.
- Group C: 8 mL bupivacaine 0.5% plus dexamethasone 8 mg (2 mL).
Patients, anesthesiologists responsible for intraoperative and postoperative assessment, surgeons, and data analysts will be blinded to group allocation.
Anesthetic technique: General anesthesia will be induced with propofol 2.5 mg/kg and fentanyl 1 µg/kg, and intubation facilitated with atracurium 0.5 mg/kg. Anesthesia will be maintained with isoflurane in oxygen and atracurium boluses, with mechanical ventilation to keep end-tidal CO2 at 35-45 mmHg.
Outcomes: Postoperative pain scores, duration of analgesia, total analgesic consumption, intraoperative hemodynamic measurements, and adverse effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel-group, three-arm, randomized, double-blind controlled trial. Eligible patients undergoing elective functional endoscopic sinus surgery will be randomly allocated in a 1:1:1 ratio to one of three groups, each receiving ultrasound-guided bilateral sphenopalatine ganglion block (10 mL total, 5 mL per side): Group A (bupivacaine 0.5% plus normal saline), Group B (bupivacaine 0.5% plus dexmedetomidine 1 µg/kg), or Group C (bupivacaine 0.5% plus dexamethasone 8 mg). Each patient remains in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Group A: Bupivacaine | Active comparator | Drug: Bupivacaine & normal salinePatients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus 2 mL of normal saline, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. |
| Group B: Bupivacaine + Dexmedetomidine | Experimental | Drug: Dexmedetomidine & Bupivacaine.Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline to 2 mL, giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. |
| Group C: Bupivacaine + Dexamethasone | Experimental | Drug: Dexamethasone & Bupivacaine.Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side), after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years.
- Elective FESS under general anesthesia.
- ASA Physical Status I-II
Key exclusion criteria (4 listed)
- Allergy to local anesthetics
- Coagulopathy or use of anticoagulants
- Anatomical nasal deformities obstructing access
- Patient refusal
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 |
|---|---|---|
| Bupivacaine & normal saline2 mL of normal saline 0.9% added to bupivacaine 0.5% (8 mL) in the sphenopalatine ganglion block to maintain a total volume of 10 mL (5 mL per side) and ensure blinding. | Drug | Group A: Bupivacaine |
| Dexmedetomidine & Bupivacaine.Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexmedetomidine 1 µg/kg diluted with normal saline 0.9% to a volume of 2 mL, giving a total volume of 10 mL (5 mL per side) | Drug | Group B: Bupivacaine + Dexmedetomidine |
| Dexamethasone & Bupivacaine.Patients will receive ultrasound-guided bilateral sphenopalatine ganglion block with 8 mL of bupivacaine 0.5% plus dexamethasone 8 mg (2 mL), giving a total volume of 10 mL (5 mL per side) | Drug | Group C: Bupivacaine + Dexamethasone |
Primary outcome
Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS)
Time frame: At PACU arrival and at 2, 4, 6, 12, and 24 hours postoperatively
Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be compared among the three study groups.Unit of measure : score on a scale
5 secondary outcomes
Time to First Rescue Analgesia
Time frame: From the end of surgery until the first rescue analgesic dose, within the first 24 hours postoperatively.
Incidence of Emergence Agitation
Time frame: During emergence from general anesthesia and at PACU arrival
Intraoperative Mean Arterial Pressure
Time frame: From baseline assessment before induction of general anesthesia until the end of surgery
Intraoperative Heart Rate
Time frame: From baseline before induction of general anesthesia until the end of surgery.
Number of Postoperative Rescue Analgesic Doses
Time frame: First 24 hours postoperatively
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 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine & normal saline, Dexmedetomidine & Bupivacaine. and Dexamethasone & Bupivacaine. in people with Post Operative Pain and Emergence Agitation, run by Sohag 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 3 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: opening soon, as of the sponsor's last update on 2 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Nardin Ehab Halim, M.B.B.Ch (01012631360, nardinehab12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed by the Visual Analogue Scale (VAS) (time frame: At PACU arrival and at 2, 4, 6, 12, and 24 hours postoperatively). 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 Nov 2026.