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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416891
• Other study ID #: MS-426-2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 15, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Kareem MA Nawwar, M.D.
• Phone: +201003878369
• Email: drknawwar[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: July 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. ASA I & ASA II patients

2. Patients undergoing tympanomastoid surgery.

3. Age group: from 21 to 70 years old.

4. 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 < 100x10?. or drug induced bleeding disorders

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Surgical Field

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modena bleeding score	Grading of surgical field visualization	up to 5 hours
Secondary	Surgeon satisfaction	Scoring surgeon satisfaction with the 3-point scale (1: good, 2: sufficient, 3: unfavorable)	1 hour postoperatively
Secondary	Analgesia duration	Time to first call for a rescue analgesic	24 hours
Secondary	Postoperative pain	Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)	24 hours postoperatively