Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery

Study Overview
=================
Brief Summary
-----------------
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.

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

Official Title
-----------------
Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery

Conditions
-----------------
Paravertebral Block

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Drug: Dexamethasone
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine fentanyl group<br>Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block | Drug: Fentanyl<br>* Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block<br>Drug: Bupivacaine<br>* Bupivacaine<br>|
| Active Comparator: Bupivacaine dexamethasone group<br>Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block | Drug: Dexamethasone<br>* Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block<br>Drug: Bupivacaine<br>* Bupivacaine<br>|
| Active Comparator: Bupivacaine fentanyl dexamethasone group<br>Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block | Drug: Fentanyl<br>* Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block<br>Drug: Dexamethasone<br>* Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block<br>Drug: Bupivacaine<br>* Bupivacaine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request |  | one day postoperative | 
| pain assessment | 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 |