- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416891
Effect of Adding Dexamethasone to Bupivacaine 0.25% in SCPB on Surgical Field Visibility During Tympanomastoid Surgery
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Kareem MA Nawwar, M.D.
- Phone Number: +201003878369
- Email: drknawwar@cu.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Medicine, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I & ASA II patients
- Patients undergoing tympanomastoid surgery.
- Age group: from 21 to 70 years old.
- Duration of surgery less than 5 hours.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine
SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline).
|
SCPB using 10 ml of bupivacaine 0.25%
|
Active Comparator: Bupivacaine plus dexamethasone
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).
|
SCPB using dexamethasone 2 mg in 10 ml of bupivacaine 0.25%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modena bleeding score
Time Frame: up to 5 hours
|
Grading of surgical field visualization
|
up to 5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia duration
Time Frame: 24 hours
|
Time to first call for a rescue analgesic
|
24 hours
|
Surgeon satisfaction
Time Frame: 1 hour postoperatively
|
Scoring surgeon satisfaction with the 3-point scale (1: good, 2: sufficient, 3: unfavorable)
|
1 hour postoperatively
|
Postoperative pain
Time Frame: 24 hours postoperatively
|
Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohsen M Waheb, M.D., Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
- Study Director: Kareem MA Nawwar, M.D., Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
- Study Chair: Sahar MM El-Shall, M.D., Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo University
- Principal Investigator: Aboumazen A Abouhashem, M.B.B.Ch., Resident of Anesthesia, Surgical ICU & Pain Management
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Dexamethasone
- Bupivacaine
Other Study ID Numbers
- MS-426-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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