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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03480308

Enrollment

Registered

2018-03-29

Start date

2018-04-01

Completion date

2021-03-30

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paravertebral Block

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

Interventions

DRUGFentanyl

Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block

DRUGDexamethasone

Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block

DRUGBupivacaine

Bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Randomization Will be Done Using Computer Generated Tables

Intervention 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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactAmonios khalil

amonios_khalil@yahoo.com01023466456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026