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
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
Time to first analgesic request	one day postoperative

Trial Locations

Locations (1)

Amonios Khalil gerges; 🇪🇬 Assiut, Egypt