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

NCT06381401 | Recruiting Phase 4

• 1 other identifier: MS-492-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Field; Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fentanyl consumption

  up to 5 hours

• Postoperative pain

  1 hour postoperatively

• Postoperative hospital stay

  4 days

Study Arms (2)

Bupivacaine 0.25%

ACTIVE COMPARATOR

Patients will receive superficial cervical plexus block using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline).

Drug: bupivacaine 0.25%

Bupivacaine 0.125%

ACTIVE COMPARATOR

Patients will receive superficial cervical plexus block using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).

Drug: bupivacaine 0.125%

Interventions

bupivacaine 0.25% DRUG

superficial cervical plexus block using 10 ml of bupivacaine 0.25%

Bupivacaine 0.25%

bupivacaine 0.125% DRUG

superficial cervical plexus block using 10 ml of bupivacaine 0.125%

Bupivacaine 0.125%

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 21 - 70 years.
• Patients undergoing tympanomastoid surgery.
• Both genders.
• ASA physical class I and II.

You may not qualify if:

• Patient refusal.
• Uncooperative patients.
• Allergy to the drug enrolled in the study.
• Anatomical abnormality at injection site.
• Infection at injection site.
• Bleeding disorders.
• ASA physical class III and IV patients.
• Patients having significant chronic diseases as: uncontrolled asthma, cardiovascular disorders (significant arrhythmias, severe valvular diseases, congenital heart diseases, ischemic heart disease, or cardiomyopathy).
• Renal impairment (creatinine level ≥ 2mg/dl), or uncompensated chronic liver disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nevan M Mekawy, M.D.

  Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo University

  STUDY CHAIR

• 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 DIRECTOR

• Fatma A Mohamed Hassan, M.B.B.Ch.

  Resident of Anesthesia, Surgical ICU & Pain Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kareem MA Nawwar, M.D.

CONTACT

+201003878369; drknawwar@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion: June 28, 2024
• Study Completion: July 5, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

EG (1)