- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480308
Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :
Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amonios Khalil
- Phone Number: 01023466456
- Email: amonios_khalil@yahoo.com
Study Locations
-
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Assiut, Egypt
- Recruiting
- Amonios Khalil gerges
-
Contact:
- Amonios Khalil
- Phone Number: 01023466456
- Email: amonios_khalil@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-70 years.
- Sex: females
- ASA physical status: I-II.
- Operation: major breast surgery
Exclusion Criteria:
- - Patient refusal.
- History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- Coagulation disorders.
- Infection at the puncture site
- Allergy to study medications.
- Chronic use of pain medications.
- Respiratory tract in¬fection within the last 2 weeks.
- Neurological deficit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine fentanyl group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
|
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Bupivacaine
|
Active Comparator: Bupivacaine dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
|
Bupivacaine
Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block
|
Active Comparator: Bupivacaine fentanyl dexamethasone group
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
|
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Bupivacaine
Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first analgesic request
Time Frame: one day postoperative
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one day postoperative
|
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pain assessment
Time Frame: one day postoperatively
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Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome
|
one day postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amonios khalil, Faculty of medicine-Assiut university-Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Dexamethasone
- Fentanyl
- Bupivacaine
Other Study ID Numbers
- paravertebral block
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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