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

Phase 4

Recruiting

• Conditions: Surgical Field; Acute Postoperative Pain
• Interventions: Drug: bupivacaine 0.25%; Drug: bupivacaine 0.125%

• Registration Number: NCT06381401
• Lead Sponsor: Cairo University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-06-28
• Study Completion: 2024-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adults between 21 - 70 years.
2. Patients undergoing tympanomastoid surgery.
3. Both genders.
4. ASA physical class I and II.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 0.25%	bupivacaine 0.25%	Patients will receive superficial cervical plexus block using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline).
Bupivacaine 0.125%	bupivacaine 0.125%	Patients will receive superficial cervical plexus block using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).

Primary Outcome Measures

Name	Time	Method
The total consumption of IV glyceryl trinitrate	up to 5 hours	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)

Secondary Outcome Measures

Name	Time	Method
Fentanyl consumption	up to 5 hours	Total intraoperative consumption of fentanyl
Postoperative pain	1 hour postoperatively	Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)
Postoperative hospital stay	4 days	Duration of postoperative hospital stay in days

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt