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Surgical FieldPhase 4NCT06416891

Effect of Adding Dexamethasone to Bupivacaine 0.25% in SCPB on Surgical Field Visibility During Tympanomastoid Surgery

A Phase 4 study testing bupivacaine 0.25% and dexamethasone 2 mg in bupivacaine 0.25% in people with Surgical Field and Postoperative Pain, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Surgical Field, Postoperative Pain
What is being tested?
bupivacaine 0.25% and dexamethasone 2 mg in bupivacaine 0.25%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteEgypt
Study dates
15 May 2024to 15 Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I \& ASA II patients
  • Patients undergoing tympanomastoid surgery.
  • Age group: from 21 to 70 years old.
  • Duration of surgery less than 5 hours.

Who cannot join

  • Patient refusal.
  • Uncooperative patients.
  • Allergy to local anesthetics or dexamethasone.
  • Anatomical abnormalities include malformations, deformities, growths, or structural irregularities.
  • Infection at injection site.
  • Coagulopathy: PTT > 40 seconds, INR > 1.4, platelet count < 100x10⁹. or drug induced bleeding disorders

Trial locations and contacts

1 site in 1 country.

Kareem MA Nawwar, M.D. contact

+201003878369

drknawwar@cu.edu.eg

Egypt1 site
  • Faculty of Medicine, Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: Effect of Adding Dexamethasone to Bupivacaine 0.25% in Superficial Cervical Plexus Block on Surgical Field Visibility During Tympanomastoid Surgery in Adults, A Randomized Controlled Study

The aim of this study is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery.

Read the detailed description

Tympanomastoid surgery is a commonly performed otological procedure performed to treat various middle ear pathologies, including chronic otitis media, cholesteatoma, and mastoiditis (1). One of the most significant complications associated with tympanomastoid surgery is bleeding, which can result in surgical difficulties, prolonged operative time, and increased morbidity (2).

Pain is also a major concern post-surgery and can lead to patient discomfort and dissatisfaction (3). Achieving optimal surgical field visibility is of paramount importance to ensure precise and safe surgical interventions. However, the presence of intraoperative bleeding and inadequate visualization can significantly impede the surgeon's ability to perform the procedure effectively, leading to potential complications and suboptimal outcomes (4).

Conventional methods for pain management during tympanomastoid surgery often involve general anesthesia or local infiltration of anesthetic agents around the surgical site. However, these techniques may not adequately address pain control and can be associated with unwanted systemic side effects (5).

To minimize bleeding and pain and improve surgical field visualization, anesthetic techniques such as induced hypotension have been used to achieve adequate homeostasis and surgical field visualization during surgery (4).

Induced hypotension involves reducing systemic blood pressure, thereby decreasing blood flow to the surgical site, minimizing the risk of bleeding, and improving the surgical field's visualization, leading to better surgical outcomes (5). However, induced hypotension can lead to cerebral hypoperfusion, organ damage, and other serious complications (6).

The use of regional anesthesia techniques, such as ultrasound-guided superficial cervical plexus block (SCPB), has gained considerable attention as a potential adjunct to general anesthesia (7). SCPB block involves the deposition of local anesthetic agents around the superficial cervical plexus, which provides sensory innervation to the ear, mastoid, and surrounding structures (8).

The SCPB provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions (9). Also, the superficial cervical plexus provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery (10).

Modern medicine focuses on enhancing patient outcomes and reducing surgical complications through improved surgical field visualization. Advanced imaging technologies like intraoperative MRI or CT scanners offer real-time, high-resolution images, aiding accurate tumor localization (11). Fluorescence-guided agents like indocyanine green enhance visualization of blood vessels, lymph nodes, and tumors during surgery. Augmented reality (AR) and virtual reality (VR) systems provide valuable guidance, allowing surgeons to identify critical structures, plan optimal incisions, and simulate complex procedures pre-surgery. Robot-assisted surgery offers enhanced precision and 3D visualization through high-definition cameras. These combined methods lead to safer and more effective surgical interventions (12).

Recent studies have suggested that combining bupivacaine, a long-acting local anesthetic, with dexamethasone, a potent anti-inflammatory agent, may offer several advantages (13). Bupivacaine provides prolonged pain relief, while dexamethasone reduces local inflammation and edema, potentially improving surgical field visibility (14).

To our knowledge, this is the first randomized clinical trial investigating the effect of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery in adults.

Being tested
bupivacaine 0.25%, dexamethasone 2 mg in bupivacaine 0.25%
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bupivacaine 0.25%Drug

    SCPB using 10 ml of bupivacaine 0.25%

  • dexamethasone 2 mg in bupivacaine 0.25%Drug

    SCPB using dexamethasone 2 mg in 10 ml of bupivacaine 0.25%

Study groups in NCT06416891
Study groupRoleWhat they receive
BupivacaineActive comparatorSCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline).
Receives: Drug: bupivacaine 0.25%
Bupivacaine plus dexamethasoneActive comparatorSCPB will be administered using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + dexamethasone 0.5 ml + 4.5 ml of normal saline).
Receives: Drug: dexamethasone 2 mg in bupivacaine 0.25%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modena bleeding score

    Grading of surgical field visualization

    Measured: up to 5 hours

Secondary outcomes (3)
  1. Surgeon satisfaction

    Scoring surgeon satisfaction with the 3-point scale (1: good, 2: sufficient, 3: unfavorable)

    Measured: 1 hour postoperatively

  2. Analgesia duration

    Time to first call for a rescue analgesic

    Measured: 24 hours

  3. Postoperative pain

    Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)

    Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start15 May 2024 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion15 Jul 2024 (estimated)

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416891
Sponsor's protocol ID
MS-426-2023
Status last verified
May 2024
First submitted
12 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing bupivacaine 0.25% and dexamethasone 2 mg in bupivacaine 0.25% in people with Surgical Field and Postoperative Pain, run by Cairo 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 6 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kareem MA Nawwar, M.D. (+201003878369, drknawwar@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modena bleeding score (time frame: up to 5 hours). 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 17 May 2024.

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