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

Paravertebral Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480308
• Other study ID #: paravertebral block
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2021
• Source: Assiut University
• Contact: Amonios khalil
• Phone: 01023466456
• Email: amonios_khalil[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: March 30, 2021
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Paravertebral Block

Intervention

Drug:
• Fentanyl
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 µg/kg in paravertebral block
• Dexamethasone
Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block
• Bupivacaine
Bupivacaine

Locations

Country	Name	City	State
Egypt	Amonios Khalil gerges	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic request		one day postoperative
Primary	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