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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Modena bleeding score
Study Overview
Brief 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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bupivacaine
SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline).
Intervention: bupivacaine 0.25% (Drug)
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).
Intervention: dexamethasone 2 mg in bupivacaine 0.25% (Drug)
Outcomes
Primary Outcomes
Modena bleeding score
Time Frame: up to 5 hours
Grading of surgical field visualization
Secondary Outcomes
- Analgesia duration(24 hours)
- Postoperative pain(24 hours postoperatively)
- Surgeon satisfaction(1 hour postoperatively)
Investigators
Kareem Mohammed Assem Nawwar
Lecturer
Cairo University