Ultrasound Guided Nerve BlockNCT07275450
Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia
A study testing Ultrasound-guided regional anesthesia group in people with Ultrasound Guided Nerve Block and Anesthesia , Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Guided Nerve Block, Anesthesia , Analgesia
- What is being tested?
- Ultrasound-guided regional anesthesia group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 1 Oct 2026
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients acceptance
- Age: 21-65 years old
- Sex: both sex (males or females).
- Physical status: American Society Anesthesiologist (ASA) І and II.
- Patients will be scheduled for elective unilateral tympanoplasty.
Who cannot join
- Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
- Neurological disorders affecting sensation in the head and neck.
- Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
- History of previous neck or parotid surgery affecting nerve anatomy.
- BMI > 35 (if it may interfere with ultrasound visualization or landmark identification).
- Pregnancy.
- Advanced cardiovascular, respiratory, hepatic and renal diseases
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
faculty of human medicine, Zagazig university hospitals
Zagazig
Ahmed Hegab, MD, 01000089347 ext. 002, dinamaghraby@yahoo.com
About this study
Official title: Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia
Read the detailed description
- To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:
- To assess the time of discharge from post anesthesia care unit
- To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).
- To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.
- To assess the incidence of block-related complications (such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity) or surgery related complications as nausea and vomiting
- Being tested
- Ultrasound-guided regional anesthesia group, Control group
- Keywords
- Ultrasound guided regional anesthesia, General anesthesia, Awake tympanoplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided regional anesthesia groupProcedure or surgery
patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.
Control groupOther
patients will receive general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided regional anesthesia group | Active comparator | patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread. Receives: Procedure: Ultrasound-guided regional anesthesia group |
| Control group | Sham comparator | patients will receive general anesthesia Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of discharge from Post Anesthesia Care Unit (PACU)
The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score
Measured: 2 hours postoperative
Secondary outcomes (10)
Intraoperative mean arterial blood pressure
Intraoperative changes in mean arterial blood pressure (mmHg)
Measured: 0 minute (basal) and every 5 minutes up to 2 hours
Pain intensity by using Numerical Rating Scale (NRS)
It is a scale from 0 to 10, where 0=no pain and 10= worst pain
Measured: Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
Block success rate
The number of patients converted to general anesthesia
Measured: 15-20 minutes (from finishing block till start surgery)
Quality of surgical field
quality of surgical field by Modena Bleeding Score (MBS) is a validated categorical scale designed to measure the quality of the surgical field in relation to bleeding during endoscopic surgery. It features five grades (1= no bleeding, 2= bleeding easily controlled by suction, 3= bleeding that slows surgical procedure, 4= most maneuvers are dedicated to bleeding control and 5= bleeding is so sever that only procedures aimed at controlling bleeding)
Measured: duration of surgery (intraoperative)
Time to first request of analgesia
Time to first request of analgesia (pethidine)
Measured: 24 hours
Total postoperative analgesic consumption
total postoperative pethidine consumption
Measured: 24 hours
Patient satisfaction by Likert score
patient satisfaction by Likert score: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
Measured: 24 hours
Surgeon satisfaction
Surgeon satisfaction by asking the surgeon to rate satisfaction at the end of surgery (4 =excellent, 3=good, 2=fair, 1=poor, 0=extremely poor)
Measured: duration of surgery (intraoperative)
The incidence of block-related complications or surgery related complications
To assess the incidence of block-related complications, such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity or surgery related complications (e.g. nausea and vomiting)
Measured: 24 hours
Intraoperative heart rate ( beat per minute)
measure intraoperative changes in heart rate
Measured: before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start10 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided Nerve BlockStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275450
- Sponsor's protocol ID
- 1841
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07275450
- Acronym / sponsor ID
- 1841
- Keywords
- Ultrasound guided regional anesthesia, General anesthesia, Awake tympanoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia
Detailed description
- To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:
- To assess the time of discharge from post anesthesia care unit
- To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).
- To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.
- To assess the incidence of block-related complications (such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity) or surgery related complications as nausea and vomiting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided regional anesthesia group | Active comparator | Procedure: Ultrasound-guided regional anesthesia grouppatients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread. |
| Control group | Sham comparator | Other: Control grouppatients will receive general anesthesia |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients acceptance
- Age: 21-65 years old
- Sex: both sex (males or females).
- Physical status: American Society Anesthesiologist (ASA) І and II.
- Patients will be scheduled for elective unilateral tympanoplasty.
Key exclusion criteria (7 listed)
- Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
- Neurological disorders affecting sensation in the head and neck.
- Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
- History of previous neck or parotid surgery affecting nerve anatomy.
- BMI > 35 (if it may interfere with ultrasound visualization or landmark identification).
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 |
|---|---|---|
| Ultrasound-guided regional anesthesia grouppatients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread. | Procedure or surgery | Ultrasound-guided regional anesthesia group |
| Control grouppatients will receive general anesthesia. | Other | Control group |
Primary outcome
The time of discharge from Post Anesthesia Care Unit (PACU)
Time frame: 2 hours postoperative
The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score
10 secondary outcomes
Intraoperative mean arterial blood pressure
Time frame: 0 minute (basal) and every 5 minutes up to 2 hours
Pain intensity by using Numerical Rating Scale (NRS)
Time frame: Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
Block success rate
Time frame: 15-20 minutes (from finishing block till start surgery)
Quality of surgical field
Time frame: duration of surgery (intraoperative)
Time to first request of analgesia
Time frame: 24 hours
Total postoperative analgesic consumption
Time frame: 24 hours
Patient satisfaction by Likert score
Time frame: 24 hours
Surgeon satisfaction
Time frame: duration of surgery (intraoperative)
The incidence of block-related complications or surgery related complications
Time frame: 24 hours
Intraoperative heart rate ( beat per minute)
Time frame: before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours
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 11 Dec 2025.
- 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 study testing Ultrasound-guided regional anesthesia group in people with Ultrasound Guided Nerve Block and Anesthesia , Analgesia, run by Zagazig 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 7 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 11 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Dina Salem, MD (0109933513 ext. 002, dinamaghraby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of discharge from Post Anesthesia Care Unit (PACU) (time frame: 2 hours postoperative). 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 11 Dec 2025.