A Phase 4 interventional study of Bupivacaine & normal saline and Dexmedetomidine & Bupivacaine. in Post Operative Pain, Emergence Agitation and Functional Endoscopic Sinus Surgery, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Sohag University · Phase 4, Interventional, and Supportive care
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.
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.
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.
5,259 studies on the registry are indexed under Pain, Postoperative; 1,163 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,490 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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.
Drug: Bupivacaine & normal saline
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.
Drug: Dexmedetomidine & 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.
Drug: Dexamethasone & Bupivacaine.
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.
Drug pages: 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)
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)
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
Time frame: At PACU arrival and at 2, 4, 6, 12, and 24 hours postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: First 24 hours postoperatively
Plan to share: Undecided
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Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 494 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 7 months is below that.
Counting every sponsor, half of 500 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Bupivacaine