A Phase 2 interventional study of Bupivacaine and Dexmedetomidine in Postoperative Pain and Middle Ear Surgery, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Minia University · Phase 2, Interventional, and Supportive care
This randomized, double-blind, controlled study will evaluate whether adding dexmedetomidine to bupivacaine in an ultrasound-guided greater auricular nerve block prolongs pain relief after middle ear surgery. Adults undergoing elective middle ear surgery under general anesthesia will receive the block before induction, either with bupivacaine alone or with bupivacaine plus dexmedetomidine. The main outcome is how long pain relief lasts after the block. Other outcomes include pain scores, opioid use, emergence agitation, hemodynamic changes, and side effects.
Middle ear surgeries require stable hemodynamics, smooth emergence, and effective postoperative analgesia. The greater auricular nerve supplies the auricle and the skin over the mastoid, and blocking it can reduce opioid requirements. Local anesthetics alone have a limited duration of action, so adjuvants such as dexmedetomidine, a selective alpha-2 agonist, are used to prolong block duration.
Forty adults (American Society of Anesthesiologists physical status I-II) scheduled for elective middle ear surgery will be randomly allocated into two equal groups using a computer-generated sequence with sealed opaque envelopes. The block is performed by an anesthesiologist not involved in data collection. Participants and outcome assessors are blinded to group allocation. All patients receive standardized general anesthesia and the same rescue analgesia protocol.
Outcomes are recorded intraoperatively and for 24 hours after surgery.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Inclusion Criteria:
Exclusion Criteria:
Ultrasound-guided greater auricular nerve block before induction of general anesthesia using 2 ml bupivacaine 0.25% plus 1 ml normal saline (total volume 3 ml).
Drug: Bupivacaine · Drug: Normal saline · Procedure: Ultrasound-guided greater auricular nerve block
Ultrasound-guided greater auricular nerve block before induction of general anesthesia using 2 ml bupivacaine 0.25% plus 1 ml dexmedetomidine 0.5 µg/kg (total volume 3 ml).
Drug: Bupivacaine · Drug: Dexmedetomidine · Procedure: Ultrasound-guided greater auricular nerve block
2 ml of bupivacaine 0.25% injected around the greater auricular nerve under ultrasound guidance before induction of general anesthesia.
1 ml of dexmedetomidine 0.5 µg/kg added to bupivacaine in the greater auricular nerve block.
1 ml of normal saline 0.9% added to 2 ml bupivacaine 0.25% in the greater auricular nerve block.
Ultrasound-guided block of the greater auricular nerve performed before induction of general anesthesia in both groups.
Duration of Analgesia
Time from completion of the greater auricular nerve block until the patient's first request for rescue analgesia after surgery.
Time frame: 24 hours after surgery
Postoperative Pain Intensity (Numeric Rating Scale)
Pain intensity measured using the Numeric Rating Scale (0 = no pain, 10 = worst pain) at baseline and at 1, 2, 4, 6, 12, and 24 hours after surgery.
Time frame: Baseline and up to 24 hours after surgery
Opioid Consumption
Total fentanyl consumed intraoperatively and total opioid (nalbuphine) requirement within 24 hours after surgery.
Time frame: Intraoperative and up to 24 hours after surgery
Emergence Agitation (Riker Sedation-Agitation Scale)
Emergence agitation assessed using the Riker Sedation-Agitation Scale (1 = unarousable to 7 = dangerous agitation).
Time frame: Immediately after extubation
Heart rate
Heart rate in beats per minute recorded at baseline, after the block, after induction, at skin incision, every 15 minutes intraoperatively, and at 1, 2, 6, 12, and 24 hours postoperatively.
Time frame: Baseline up to 24 hours after surgery
Operative Time
Duration of surgery in minutes.
Time frame: Intraoperative
Incidence of Adverse Effects
Incidence of bradycardia, hypotension, nausea, vomiting, sedation, and local complications at the injection site.
Time frame: Up to 24 hours after surgery
Mean Arterial Pressure
Mean arterial pressure in mmHg recorded at baseline, after the block, after induction, at skin incision, every 15 minutes intraoperatively, and at 1, 2, 6, 12, and 24 hours postoperatively.
Time frame: Baseline up to 24 hours after surgery
Oxygen Saturation
Peripheral oxygen saturation (SpO2) in percent recorded at baseline, after the block, after induction, at skin incision, every 15 minutes intraoperatively, and at 1, 2, 6, 12, and 24 hours postoperatively.
Time frame: Baseline up to 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
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 ↗
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Studies of the drug tested here: Dexmedetomidine