Postoperative PainPhase 2NCT07878533
Dexmedetomidine as an Adjuvant to Greater Auricular Nerve Block in Middle Ear Surgeries
A Phase 2 study testing Bupivacaine, Dexmedetomidine and Normal saline in people with Postoperative Pain and Middle Ear Surgery, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain, Middle Ear Surgery
- What is being tested?
- Bupivacaine, Dexmedetomidine and Normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2026to 30 May 2027
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective middle ear surgery under general anesthesia
- Aged 18-70 years
- ASA physical status I or II
- BMI ≤ 35 kg/m2
Who cannot join
- Patient refusal
- Known allergy to local anesthetics or dexmedetomidine
- Coagulation disorders or anticoagulant therapy
- Infection at the injection site
- History of head and neck surgery
- Significant cardiovascular disease (heart block, severe bradycardia, or uncontrolled hypertension)
Show all 10Show fewer
- Hepatic or renal impairment
- Chronic opioid or analgesic use
- Psychiatric disorders or inability to cooperate
- Pregnancy or lactation
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, 1 recruiting
- Recruiting
Minia university hospital
Minya
Shimaa Hassan, MBBCh, +20 1062547761, sm74878@gmail.com
About this study
Official title: Efficacy of Dexmedetomidine as an Adjuvant to Ultrasound-Guided Greater Auricular Nerve Block for Middle Ear Surgeries: A Randomized Double-Blinded Controlled Study
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Middle Ear Surgery
- Being tested
- Bupivacaine, Dexmedetomidine, Normal saline, Ultrasound-guided greater auricular nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
2 ml of bupivacaine 0.25% injected around the greater auricular nerve under ultrasound guidance before induction of general anesthesia.
DexmedetomidineDrug
1 ml of dexmedetomidine 0.5 µg/kg added to bupivacaine in the greater auricular nerve block.
Normal salineDrug
1 ml of normal saline 0.9% added to 2 ml bupivacaine 0.25% in the greater auricular nerve block.
Ultrasound-guided greater auricular nerve blockProcedure or surgery
Ultrasound-guided block of the greater auricular nerve performed before induction of general anesthesia in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control) | Active comparator | 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). Receives: Drug: Bupivacaine; Drug: Normal saline; Procedure: Ultrasound-guided greater auricular nerve block |
| Group BD (Dexmedetomidine) | Experimental | 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). Receives: Drug: Bupivacaine; Drug: Dexmedetomidine; Procedure: Ultrasound-guided greater auricular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
Time from completion of the greater auricular nerve block until the patient's first request for rescue analgesia after surgery.
Measured: 24 hours after surgery
Secondary outcomes (8)
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.
Measured: Baseline and up to 24 hours after surgery
Opioid Consumption
Total fentanyl consumed intraoperatively and total opioid (nalbuphine) requirement within 24 hours after surgery.
Measured: 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).
Measured: 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.
Measured: Baseline up to 24 hours after surgery
Operative Time
Duration of surgery in minutes.
Measured: Intraoperative
Incidence of Adverse Effects
Incidence of bradycardia, hypotension, nausea, vomiting, sedation, and local complications at the injection site.
Measured: 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.
Measured: 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.
Measured: Baseline up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start25 Sep 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Minia 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: bupivacaine with saline versus bupivacaine with dexmedetomidine.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Mohamed Khalifa Hassan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878533
- Sponsor's protocol ID
- 2063:7/2026
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine as an Adjuvant to Ultrasound-Guided Greater Auricular Nerve Block for Middle Ear Surgeries: A Randomized Double-Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT07878533
- Acronym / sponsor ID
- 2063:7/2026
- Conditions
- Postoperative Pain, Middle Ear Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 16 Oct 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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups: bupivacaine with saline versus bupivacaine with dexmedetomidine.
| Arm | Type | Receives |
|---|---|---|
| Group C (Control) | Active comparator | Drug: Bupivacaine, Drug: Normal saline, Procedure: Ultrasound-guided greater auricular nerve blockUltrasound-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). |
| Group BD (Dexmedetomidine) | Experimental | Drug: Bupivacaine, Drug: Dexmedetomidine, Procedure: Ultrasound-guided greater auricular nerve blockUltrasound-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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective middle ear surgery under general anesthesia
- Aged 18-70 years
- ASA physical status I or II
- BMI ≤ 35 kg/m2
Key exclusion criteria (10 listed)
- Patient refusal
- Known allergy to local anesthetics or dexmedetomidine
- Coagulation disorders or anticoagulant therapy
- Infection at the injection site
- History of head and neck surgery
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 |
|---|---|---|
| Bupivacaine2 ml of bupivacaine 0.25% injected around the greater auricular nerve under ultrasound guidance before induction of general anesthesia. | Drug | Group BD (Dexmedetomidine), Group C (Control) |
| Dexmedetomidine1 ml of dexmedetomidine 0.5 µg/kg added to bupivacaine in the greater auricular nerve block. | Drug | Group BD (Dexmedetomidine) |
| Normal saline1 ml of normal saline 0.9% added to 2 ml bupivacaine 0.25% in the greater auricular nerve block. | Drug | Group C (Control) |
| Ultrasound-guided greater auricular nerve blockUltrasound-guided block of the greater auricular nerve performed before induction of general anesthesia in both groups. | Procedure or surgery | Group BD (Dexmedetomidine), Group C (Control) |
Primary outcome
Duration of Analgesia
Time frame: 24 hours after surgery
Time from completion of the greater auricular nerve block until the patient's first request for rescue analgesia after surgery.
8 secondary outcomes
Postoperative Pain Intensity (Numeric Rating Scale)
Time frame: Baseline and up to 24 hours after surgery
Opioid Consumption
Time frame: Intraoperative and up to 24 hours after surgery
Emergence Agitation (Riker Sedation-Agitation Scale)
Time frame: Immediately after extubation
Heart rate
Time frame: Baseline up to 24 hours after surgery
Operative Time
Time frame: Intraoperative
Incidence of Adverse Effects
Time frame: Up to 24 hours after surgery
Mean Arterial Pressure
Time frame: Baseline up to 24 hours after surgery
Oxygen Saturation
Time frame: Baseline up to 24 hours after surgery
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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 2 study testing Bupivacaine, Dexmedetomidine and Normal saline in people with Postoperative Pain and Middle Ear Surgery, run by Minia 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Analgesia (time frame: 24 hours after surgery). 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 16 Oct 2026.