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.
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.
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.
- Conditions
- Surgical Field, Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | SCPB 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 dexamethasone | Active comparator | SCPB 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.
Modena bleeding score
Grading of surgical field visualization
Measured: up to 5 hours
Secondary outcomes (3)
Surgeon satisfaction
Scoring surgeon satisfaction with the 3-point scale (1: good, 2: sufficient, 3: unfavorable)
Measured: 1 hour postoperatively
Analgesia duration
Time to first call for a rescue analgesic
Measured: 24 hours
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.
- First posted16 May 2024
- Study start15 May 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical FieldStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Sahar MM El-Shall, M.D., Study chair, Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityMohsen M Waheb, M.D., Study director, Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityKareem MA Nawwar, M.D., Study director, Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityAboumazen A Abouhashem, M.B.B.Ch., Principal investigator, Resident of Anesthesia, Surgical ICU & Pain Management
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06416891
- Acronym / sponsor ID
- MS-426-2023
- Conditions
- Surgical Field, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 16 May 2024 (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 is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: bupivacaine 0.25%SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline). |
| Bupivacaine plus dexamethasone | Active comparator | Drug: dexamethasone 2 mg in bupivacaine 0.25%SCPB 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). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I \& ASA II patients
- Patients undergoing tympanomastoid surgery.
- Age group: from 21 to 70 years old.
- Duration of surgery less than 5 hours.
Key exclusion criteria (6 listed)
- Patient refusal.
- Uncooperative patients.
- Allergy to local anesthetics or dexamethasone.
- Anatomical abnormalities include malformations, deformities, growths, or structural irregularities.
- Infection at injection site.
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 |
|---|---|---|
| bupivacaine 0.25%SCPB using 10 ml of bupivacaine 0.25% | Drug | Bupivacaine |
| dexamethasone 2 mg in bupivacaine 0.25%SCPB using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% | Drug | Bupivacaine plus dexamethasone |
Primary outcome
Modena bleeding score
Time frame: up to 5 hours
Grading of surgical field visualization
3 secondary outcomes
Surgeon satisfaction
Time frame: 1 hour postoperatively
Analgesia duration
Time frame: 24 hours
Postoperative pain
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Related trials for Surgical Field
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
Fospropofol Disodium
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Not yet recruitingPhase 4
Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications
Thromboembolic Event, FDP
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. This study is not recruiting at the moment.
Sahar MM El-Shall, M.D. study chair
Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo University
Mohsen M Waheb, M.D. study director
Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
Kareem MA Nawwar, M.D. study director
Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
1 site in 1 country: see every site and its status.
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.