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

NCT ID: NCT03480308

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-03-30

Brief Summary

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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

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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

Conditions

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Paravertebral Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Randomization Will be Done Using Computer Generated Tables

Study Groups

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Bupivacaine fentanyl group

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Bupivacaine

Intervention Type DRUG

Bupivacaine

Bupivacaine dexamethasone group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Bupivacaine

Intervention Type DRUG

Bupivacaine

Bupivacaine fentanyl dexamethasone group

Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Bupivacaine

Intervention Type DRUG

Bupivacaine

Interventions

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Fentanyl

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Bupivacaine

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amonios khalil

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amonios khalil

Role: STUDY_DIRECTOR

Faculty of medicine-Assiut university-Egypt

Locations

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Amonios Khalil gerges

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amonios khalil

Role: CONTACT

01023466456

Facility Contacts

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Amonios Khalil

Role: primary

01023466456

Other Identifiers

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paravertebral block

Identifier Type: -

Identifier Source: org_study_id

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