Comparing two concentrations of bupivacaine for pain management in ear surgeries

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

This study tests which of two strengths of a pain medication called bupivacaine works better for adults having ear surgery to help them feel less pain and have a smoother operation.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: Cairo University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06381401 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two different concentrations of bupivacaine (0.125% and 0.25%) in performing a superficial cervical plexus block for patients undergoing tympanomastoid surgeries. The aim is to determine which concentration provides better pain relief and minimizes bleeding during surgery, thereby improving surgical conditions. The study focuses on adult patients aged 21 to 70 who are classified as ASA physical class I and II. By using regional nerve blocks, the trial seeks to enhance patient outcomes and reduce complications associated with tympanomastoid procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 to 70 who are scheduled for tympanomastoid surgery and classified as ASA physical class I or II.

Not a fit: Patients who may not benefit from this study include those with significant chronic diseases, allergies to bupivacaine, or those classified as ASA physical class III or IV.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and reduced surgical complications for patients undergoing tympanomastoid surgeries.

How similar studies have performed: Other studies have shown positive outcomes with regional nerve blocks in similar surgical contexts, suggesting that this approach is promising.

Eligibility criteria

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.

Where this trial is running

Cairo

• Faculty of Medicine, Cairo University — Cairo, Egypt (RECRUITING)

Study contacts

• Principal investigator: Fatma A Mohamed Hassan, M.B.B.Ch. — Resident of Anesthesia, Surgical ICU & Pain Management
• Study coordinator: Kareem MA Nawwar, M.D.

Conditions: Surgical Field, Acute Postoperative Pain