Trials Sponsors Conditions Drugs Pricing

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

Age21 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

ASA I \& ASA II patients
Patients undergoing tympanomastoid surgery.

Sponsors & Collaborators

Cairo University
Otherlead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compounds

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2024

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Bupivacaine

Bupivacaine plus dexamethasone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Bupivacaine

Bupivacaine plus dexamethasone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations