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Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia

ConditionsUltrasound Guided Nerve BlockAnesthesia , Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorZagazig University

About this trial

The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients acceptance

Age: 21-65 years old

Sex: both sex (males or females).

Physical status: American Society Anesthesiologist (ASA) І and II.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided regional anesthesia group

    Procedure/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 group

    Other intervention

    patients will receive general anesthesia.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Ultrasound-guided regional anesthesia groupActive comparator 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 hours postoperative

Secondary outcomes

1

Intraoperative mean arterial blood pressure

Intraoperative changes in mean arterial blood pressure (mmHg)

Time frame
0 minute (basal) and every 5 minutes up to 2 hours
2

Pain intensity by using Numerical Rating Scale (NRS)

It is a scale from 0 to 10, where 0=no pain and 10= worst pain

Time frame
Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
3

Block success rate

The number of patients converted to general anesthesia

Time frame
15-20 minutes (from finishing block till start surgery)
4

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)

Time frame
duration of surgery (intraoperative)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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