Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults

Acute Postoperative Pain Clinical Trial

Official title:

The Efficacy of Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries, A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381401
• Other study ID #: MS-492-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: July 5, 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

Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.

The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.

This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.

This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% & 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.

The investigators hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.

This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. Participants were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 5, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults between 21 - 70 years.

2. Patients undergoing tympanomastoid surgery.

3. Both genders.

4. ASA physical class I and II.

Exclusion Criteria:

1. Patient refusal.

2. Uncooperative patients.

3. Allergy to the drug enrolled in the study.

4. Anatomical abnormality at injection site.

5. Infection at injection site.

6. Bleeding disorders.

7. ASA physical class III and IV patients.

8. Patients having significant chronic diseases as: uncontrolled asthma, cardiovascular disorders (significant arrhythmias, severe valvular diseases, congenital heart diseases, ischemic heart disease, or cardiomyopathy).

9. Renal impairment (creatinine level = 2mg/dl), or uncompensated chronic liver disease.

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative
• Surgical Field

Intervention

Drug:
• bupivacaine 0.25%
superficial cervical plexus block using 10 ml of bupivacaine 0.25%
• bupivacaine 0.125%
superficial cervical plexus block using 10 ml of bupivacaine 0.125%

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	The total consumption of IV glyceryl trinitrate	The total consumption of IV glyceryl trinitrate administered to maintain a surgical field with a Boezaart bleeding score =2 (grade 0 = no bleeding, grade 5 = severe bleeding threatening surgical field)	up to 5 hours
Secondary	Fentanyl consumption	Total intraoperative consumption of fentanyl	up to 5 hours
Secondary	Postoperative pain	Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)	1 hour postoperatively
Secondary	Postoperative hospital stay	Duration of postoperative hospital stay in days	4 days