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

Not Applicable

• Conditions: Paravertebral Block
• Interventions: Drug: Fentanyl; Drug: Dexamethasone; Drug: Bupivacaine

• Registration Number: NCT03480308
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2018-04-01
• Primary Completion: 2019-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-21
• Last Update Posted: 2021-02-23
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine fentanyl group	Fentanyl	Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Bupivacaine fentanyl group	Bupivacaine	Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Bupivacaine dexamethasone group	Bupivacaine	Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
Bupivacaine dexamethasone group	Dexamethasone	Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
Bupivacaine fentanyl dexamethasone group	Fentanyl	Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
Bupivacaine fentanyl dexamethasone group	Bupivacaine	Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
Bupivacaine fentanyl dexamethasone group	Dexamethasone	Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request	one day postoperative
pain assessment	one day postoperatively	Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome

Trial Locations

Locations (1)

Amonios Khalil gerges; 🇪🇬 Assiut, Egypt