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

NCT06416891 | Not Yet Recruiting Phase 4

• 1 other identifier: MS-426-2023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Field; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Modena bleeding score

  Grading of surgical field visualization

  up to 5 hours

Secondary Outcomes (3)

• Surgeon satisfaction

  1 hour postoperatively

• Analgesia duration

  24 hours

• Postoperative pain

  24 hours postoperatively

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline).

Drug: bupivacaine 0.25%

Bupivacaine plus dexamethasone

ACTIVE COMPARATOR

SCPB will be administered using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + dexamethasone 0.5 ml + 4.5 ml of normal saline).

Drug: dexamethasone 2 mg in bupivacaine 0.25%

Interventions

bupivacaine 0.25% DRUG

SCPB using 10 ml of bupivacaine 0.25%

Bupivacaine

dexamethasone 2 mg in bupivacaine 0.25% DRUG

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

Bupivacaine plus dexamethasone

Eligibility Criteria

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

You may qualify if:

• ASA I \& ASA II patients
• Patients undergoing tympanomastoid surgery.
• Age group: from 21 to 70 years old.
• Duration of surgery less than 5 hours.

You may not qualify if:

• 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 \< 100x10⁹. or drug induced bleeding disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sahar MM El-Shall, 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

• Aboumazen A Abouhashem, 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: May 12, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

EG (1)